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  • Dispositivo 3309
  • Fabricante 731
  • Evento 124969
  • Implante 166
Retiro De Equipo (Recall) de Device Recall Endophotocoagulation Delivery 4EP1 of GYC1000 Green L...
  • Tipo de evento
    Recall
  • ID del evento
    71527
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2068-2015
  • Fecha de inicio del evento
    2015-03-25
  • Fecha de publicación del evento
    2015-07-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138109
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Accessories to the gyc-1000 laser were missing laser aperture labels.
  • Acción
    Nidek sent Recall Notifications to doctors on March 31, 2015, by Federal Express. Letters were specific to the accessory involved. NIDEK detected that the laser aperture label has not been affixed on the delivery unit of GYC-1000, Green Laser Photocoagulator System and the device does not meet FDA regulation 21 CFR Subchapter J. In order to comply with FDA regulation, Nidek requests that the customer affix the enclosed laser aperture label to the Dual Delivery 4DD-1 of GYC-1000, according to the instructions attached. Please see the enclosed Laser Aperture label, instruction for affixing to the device and the response card. Nidek requests that you complete and return the response card as soon as possible. For additional information, please call Nidek at 1-800-223-9044 or visit http://usa.nidek.com
Retiro De Equipo (Recall) de Device Recall Exactech Spine, Large Set Screw
  • Tipo de evento
    Recall
  • ID del evento
    71528
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2059-2015
  • Fecha de inicio del evento
    2009-03-06
  • Fecha de publicación del evento
    2015-07-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138110
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Orthosis, spondylolisthesis spinal fixation - Product Code MNH
  • Causa
    Incorrect thread form on the screw.
  • Acción
    Consignees were notified with a Product Recall Notice on 03/06/2009 that all screws must be checked to ensure that any discrepant products to be removed from the field.
Retiro De Equipo (Recall) de Device Recall Oxford Fixed Lateral
  • Tipo de evento
    Recall
  • ID del evento
    71529
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2065-2015
  • Fecha de inicio del evento
    2015-06-03
  • Fecha de publicación del evento
    2015-07-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138113
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Template - Product Code HWT
  • Causa
    Oxford femoral drill guide lateral im adapter may have an undersized diameter that can cause an interference with pn: 32-422822, oxford microplasty im link.
  • Acción
    On 6/3/2015 an "URGENT MEDICAL DEVICE RECALL NOTICE" letter was sent to the affected distributors with instructions for locating and returning the affected product. The recall letter included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Retiro De Equipo (Recall) de Device Recall Zimmer Natural Nail System
  • Tipo de evento
    Recall
  • ID del evento
    71530
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2060-2015
  • Fecha de inicio del evento
    2015-06-17
  • Fecha de publicación del evento
    2015-07-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138114
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    A single distributed znn greater trochanter femoral nail may have been dented. potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion.
  • Acción
    On 6/17/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761. Hours of operation are Monday through Friday, 8 a.m. through 5 p.m. EST.
Retiro De Equipo (Recall) de Device Recall Bone Marrow Aspiration Needle
  • Tipo de evento
    Recall
  • ID del evento
    71533
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2188-2015
  • Fecha de inicio del evento
    2015-06-18
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138118
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Instrument, biopsy - Product Code KNW
  • Causa
    Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
  • Acción
    The recalling firm's sales force was notified of the recall on 6/17/15. The recalling firm will begin to send out Urgent Medical Device Recall letters by registered mail to affected customers on 6/18/15. Customers are instructed to inspect and quarantine and return any affected product and complete the Recal Response Form.
Retiro De Equipo (Recall) de Device Recall Ring Transjugular Intrahepatic Access Set
  • Tipo de evento
    Recall
  • ID del evento
    71430
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2100-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138147
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter, cholangiography - Product Code GBZ
  • Causa
    Cook inc. is initiating a voluntary recall of the ring transjugular intrahepatic access set and the flexor rtps introduce sheath due to complaints of the dilators being too long.
  • Acción
    Written recall communication letters were shipped via FedEx on June 05, 2015 to all US Consignees. Customers were asked to complete and return response forms and recalled products. Recalled devices will be held for final disposition and destruction. Customers wree asked to forward notices if recalled devices were further distributed. Effectivenes checks will be conducted by mail, phone and visits. Customers may contact Cook Medical Relations (800) 457-4500 or 1 (812)- 339-2235 Monday through Friday from 7:30 AM to 5:00 PM or e-mail at CustomerrelationsNA@cook medical.com.
Retiro De Equipo (Recall) de Device Recall Stryker SelectCore Variable Throw Biopsy Device, 14G,...
  • Tipo de evento
    Recall
  • ID del evento
    71429
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2102-2015
  • Fecha de inicio del evento
    2015-06-02
  • Fecha de publicación del evento
    2015-07-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138120
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Instrument, biopsy - Product Code KNW
  • Causa
    Stryker instruments is recalling the stryker selectcore variable throw biopsy device due to the potential for for the stylet to eject from the selectcore device during actuation.
  • Acción
    Stryker distributed Customer Notification Letters via Fed Ex overnight to be delivered on 06/10/2015. Customers are asked to Immediately review this Recall Notification. 2. Immediately check all stock areas and/or operating room storage and quarantine any affected product found. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you do not have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in this Notification. 4. If you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. 5. Fax (866-521-2762) or email (julie.forsyth@stryker.com) the completed Business Reply Forms; and return the recalled SelectCore devices(s) to Stryker.
Retiro De Equipo (Recall) de Device Recall Bone Marrow Biopsy Needle
  • Tipo de evento
    Recall
  • ID del evento
    71533
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2189-2015
  • Fecha de inicio del evento
    2015-06-18
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138121
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Instrument, biopsy - Product Code KNW
  • Causa
    Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
  • Acción
    The recalling firm's sales force was notified of the recall on 6/17/15. The recalling firm will begin to send out Urgent Medical Device Recall letters by registered mail to affected customers on 6/18/15. Customers are instructed to inspect and quarantine and return any affected product and complete the Recal Response Form.
Retiro De Equipo (Recall) de Device Recall Laser fibers
  • Tipo de evento
    Recall
  • ID del evento
    71534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2156-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138124
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sureflex'" reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Acción
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Retiro De Equipo (Recall) de Device Recall Laser fibers
  • Tipo de evento
    Recall
  • ID del evento
    71534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2157-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138125
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sureflex'" reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Acción
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Retiro De Equipo (Recall) de Device Recall Flexor RTPS Guiding Sheath
  • Tipo de evento
    Recall
  • ID del evento
    71430
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2101-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138148
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Introducer, catheter - Product Code DYB
  • Causa
    Cook inc. is initiating a voluntary recall of the ring transjugular intrahepatic access set and the flexor rtps introduce sheath due to complaints of the dilators being too long.
  • Acción
    Written recall communication letters were shipped via FedEx on June 05, 2015 to all US Consignees. Customers were asked to complete and return response forms and recalled products. Recalled devices will be held for final disposition and destruction. Customers wree asked to forward notices if recalled devices were further distributed. Effectivenes checks will be conducted by mail, phone and visits. Customers may contact Cook Medical Relations (800) 457-4500 or 1 (812)- 339-2235 Monday through Friday from 7:30 AM to 5:00 PM or e-mail at CustomerrelationsNA@cook medical.com.
Retiro De Equipo (Recall) de Device Recall Laser fibers
  • Tipo de evento
    Recall
  • ID del evento
    71534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2158-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138126
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sureflex'" reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Acción
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Retiro De Equipo (Recall) de Device Recall Laser fibers
  • Tipo de evento
    Recall
  • ID del evento
    71534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2159-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138127
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sureflex'" reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Acción
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Retiro De Equipo (Recall) de Device Recall Laser fibers
  • Tipo de evento
    Recall
  • ID del evento
    71534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2160-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138128
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sureflex'" reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Acción
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Retiro De Equipo (Recall) de Device Recall Laser fibers
  • Tipo de evento
    Recall
  • ID del evento
    71534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2161-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138129
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sureflex'" reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Acción
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Retiro De Equipo (Recall) de Device Recall Xl por st 25.5x220mm, bowed, Sterile,
  • Tipo de evento
    Recall
  • ID del evento
    76629
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2583-2017
  • Fecha de inicio del evento
    2017-02-28
  • Fecha de publicación del evento
    2017-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-02-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153890
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Causa
    Zimmer biomet inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
  • Acción
    Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following: 1. Review this notification and ensure affected team members are aware of the contents. 2. Complete the Certification of Acknowledgement portion of Attachment 1 a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 3. Assist the Zimmer Biomet sales representative quarantine all affected product. 4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: ¿ MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax. ¿ Online: www.fda.gov/medwatch/report.htm ¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm ¿ Fax: 1-800-FDA-0178 Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com. For questions regarding this recall call 574-371-3071.
Retiro De Equipo (Recall) de Device Recall Laser fibers
  • Tipo de evento
    Recall
  • ID del evento
    71534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2162-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138130
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sureflex reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Acción
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Retiro De Equipo (Recall) de Device Recall Laser fibers
  • Tipo de evento
    Recall
  • ID del evento
    71534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2163-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138131
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sureflex'" reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Acción
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Retiro De Equipo (Recall) de Device Recall fiber stripper
  • Tipo de evento
    Recall
  • ID del evento
    71534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2164-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138132
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sureflex'" reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Acción
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Retiro De Equipo (Recall) de Device Recall Fiber Stripper
  • Tipo de evento
    Recall
  • ID del evento
    71534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2165-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138133
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sure flex'" reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Acción
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Retiro De Equipo (Recall) de Device Recall OxiMax N560 Pulse Oximeter
  • Tipo de evento
    Recall
  • ID del evento
    71583
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2268-2015
  • Fecha de inicio del evento
    2015-06-29
  • Fecha de publicación del evento
    2015-07-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138258
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Oximeter - Product Code DQA
  • Causa
    Potential missing segments on the display that can result in misinterpretation of data.
  • Acción
    Metronic sent an Urgent Medical Device Correction letter dated June 29, 2015 to affected customers. The letter identified the adfected product, problem and actions to be taked. Customers where instructed to return the attached verification form. For questions contact your Medtronic representative.
Retiro De Equipo (Recall) de Device Recall Fiber Stripper
  • Tipo de evento
    Recall
  • ID del evento
    71534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2166-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138135
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sure flex'" reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Acción
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Retiro De Equipo (Recall) de Device Recall Fiber Stripper
  • Tipo de evento
    Recall
  • ID del evento
    71534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2167-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138137
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sureflex reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Acción
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Retiro De Equipo (Recall) de Device Recall Fiber Stripper
  • Tipo de evento
    Recall
  • ID del evento
    71534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2168-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138138
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sureflex reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Acción
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Retiro De Equipo (Recall) de Device Recall Fiber Stripper
  • Tipo de evento
    Recall
  • ID del evento
    71534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2169-2015
  • Fecha de inicio del evento
    2015-05-28
  • Fecha de publicación del evento
    2015-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138139
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sureflex reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Acción
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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