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  • Dispositivo 1211
  • Fabricante 31827
  • Evento 5885
  • Implante 4142
Retiro De Equipo (Recall) de Device Recall Axial Torque Limiting Driver
  • Tipo de evento
    Recall
  • ID del evento
    73873
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1637-2016
  • Fecha de inicio del evento
    2015-02-02
  • Fecha de publicación del evento
    2016-05-10
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145265
  • 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
    Wrench - Product Code HXC
  • Causa
    A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
  • Acción
    Consignees were sent a Bradshaw Medical "Product Withdrawal Notice" letter, date marked starting February 2, 2015. The letter specified the Part Number, Lot Number (s) and Shipped date for each consignee. The letter described the product and advised consignees to discontinue use of the product. Requested consignees to complete and return the Customer /Distribution verification Form to BMI Regulatory Affairs FAX (262) 925-1380 and to further send the "Withdrawal Notice and Customer Verification Form" to all customers to whom they have distributed the product.
Retiro De Equipo (Recall) de Device Recall Zimmer Plates and Screws
  • Tipo de evento
    Recall
  • ID del evento
    73981
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1673-2016
  • Fecha de inicio del evento
    2016-05-04
  • Fecha de publicación del evento
    2016-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145820
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Acción
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Retiro De Equipo (Recall) de Device Recall Zimmer Plates and Screws
  • Tipo de evento
    Recall
  • ID del evento
    73981
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1674-2016
  • Fecha de inicio del evento
    2016-05-04
  • Fecha de publicación del evento
    2016-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145961
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Acción
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Retiro De Equipo (Recall) de Device Recall Zimmer Universal Locking System
  • Tipo de evento
    Recall
  • ID del evento
    73981
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1675-2016
  • Fecha de inicio del evento
    2016-05-04
  • Fecha de publicación del evento
    2016-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145962
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Acción
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Retiro De Equipo (Recall) de Device Recall Zimmer Periarticular Plating System
  • Tipo de evento
    Recall
  • ID del evento
    73981
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1676-2016
  • Fecha de inicio del evento
    2016-05-04
  • Fecha de publicación del evento
    2016-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145969
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Acción
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Retiro De Equipo (Recall) de Device Recall Zimmer Plates and Screws
  • Tipo de evento
    Recall
  • ID del evento
    73981
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1677-2016
  • Fecha de inicio del evento
    2016-05-04
  • Fecha de publicación del evento
    2016-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145971
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Acción
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Retiro De Equipo (Recall) de Device Recall Zimmer M/DN Intramedullary Fixation System
  • Tipo de evento
    Recall
  • ID del evento
    73981
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1678-2016
  • Fecha de inicio del evento
    2016-05-04
  • Fecha de publicación del evento
    2016-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145973
  • 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 small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Acción
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Retiro De Equipo (Recall) de Device Recall Zimmer MagnaFx Cannulated Screw Fixation System
  • Tipo de evento
    Recall
  • ID del evento
    73981
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1679-2016
  • Fecha de inicio del evento
    2016-05-04
  • Fecha de publicación del evento
    2016-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145976
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Acción
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Retiro De Equipo (Recall) de Device Recall Zimmer Herbert Bone Screw System
  • Tipo de evento
    Recall
  • ID del evento
    73981
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1680-2016
  • Fecha de inicio del evento
    2016-05-04
  • Fecha de publicación del evento
    2016-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145978
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Acción
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Retiro De Equipo (Recall) de Device Recall Zimmer ITST intertrochanteric/subtrochanteric Intra...
  • Tipo de evento
    Recall
  • ID del evento
    73981
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1681-2016
  • Fecha de inicio del evento
    2016-05-04
  • Fecha de publicación del evento
    2016-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145981
  • 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 small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Acción
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Retiro De Equipo (Recall) de Device Recall VersaFx Femoral Fixation System
  • Tipo de evento
    Recall
  • ID del evento
    73981
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1682-2016
  • Fecha de inicio del evento
    2016-05-04
  • Fecha de publicación del evento
    2016-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145983
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • Causa
    A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Acción
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Retiro De Equipo (Recall) de Device Recall Zimmer Hgp ii acetabular cup bone Screw
  • Tipo de evento
    Recall
  • ID del evento
    73981
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1683-2016
  • Fecha de inicio del evento
    2016-05-04
  • Fecha de publicación del evento
    2016-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145987
  • 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, cemented - Product Code JDI
  • Causa
    A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Acción
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Retiro De Equipo (Recall) de Device Recall Zimmer Selftapping bone screw
  • Tipo de evento
    Recall
  • ID del evento
    73981
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1684-2016
  • Fecha de inicio del evento
    2016-05-04
  • Fecha de publicación del evento
    2016-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145990
  • 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
    A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Acción
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Retiro De Equipo (Recall) de Device Recall 8.0 mm Flexible Shaft Reamer
  • Tipo de evento
    Recall
  • ID del evento
    74080
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1912-2016
  • Fecha de inicio del evento
    2016-05-02
  • Fecha de publicación del evento
    2016-06-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146229
  • 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
    Reamer - Product Code HTO
  • Causa
    Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. the high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. this could potentially be reproduced during use and reprocessing.
  • Acción
    Depuy Synthes sent an Urgent Notice: Medical Device Recall letter on 05/02/2016 to all affected consignees. Consignees were instructed to do the following: review your inventory immediately to see if any of the affected products were being stored, and call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement order, to complete the Verification Section (page 3) and return with the product to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.
Retiro De Equipo (Recall) de Device Recall Synthes LCP DiaphysealMetaphyseal Volar Distal Radius...
  • Tipo de evento
    Recall
  • ID del evento
    74082
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1949-2016
  • Fecha de inicio del evento
    2016-05-02
  • Fecha de publicación del evento
    2016-06-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146232
  • 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
    Plate, fixation, bone - Product Code HRS
  • Causa
    Product incorrectly packaged. the labels on the outside of the box and on the lcp dia-meta volar distal radius plate inside the box are correct; however, the preprinted box which contains the lcp-dia-meta volar distal radius plate is incorrect. the box is preprinted for a 4.5 mm lcp condylar plate - distal femur.
  • Acción
    DePuy Synthes sent out an Urgent Notice to customers informing them of a package mixup and the impact it could have on users. Customers were asked to evaluate their inventory and immediately remove the affected lot (9890811) from stock. Customers were asked to call DePuy Synthes at 1800-479-6329 to obtain a Return Authorization Number for return of the affected product, fill out the verification section of the letter and mail with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Any questions, they were said to call 610-719-5450 or to contact their DePuy Synthes Sales Consultant.
Retiro De Equipo (Recall) de Device Recall TS Series Depth Gauge for Integra Ti6 Internal Fixati...
  • Tipo de evento
    Recall
  • ID del evento
    74114
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1965-2016
  • Fecha de inicio del evento
    2016-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146323
  • 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
    Plate, fixation, bone - Product Code HRS
  • Causa
    As a result of an internal investigation of a non-conformance it has been determined: 1) depth gauges from lot up15h2 exceed the overall length specification requirements. 2) depth gauges from prior lot numbers manufactured before integra acquired the product line reflect an incorrect number for the first mm depth marking on the gauge. the number should be 4, it is 6. 3) the space / holder.
  • Acción
    The firm, Integra Lifesciences, sent an "Urgent: Voluntary Medical Device Recall" letter dated 5/10/16 to affected consignees/customers via traceable courier service on 5/10/16. The letter describes the product, problem and actions to be taken. The customers were instructed to stop using and distributing product immediately; complete and return the Recall Acknowledgement and Return Form via fax to 1-609-275-9445 or email to FCA2@integralife.com, even if you do not have any of the product. Should you have any questions, please contact Customer Service at 1-866-854-8300.
Retiro De Equipo (Recall) de Device Recall Baxter Healthcare Corp.
  • Tipo de evento
    Recall
  • ID del evento
    74125
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1922-2016
  • Fecha de inicio del evento
    2015-08-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146367
  • 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
    Filler, bone void, calcium compound - Product Code MQV
  • Causa
    Baxter healthcare is issuing a voluntary recall for all lots of actifuse abx and actifuse mis system products with expiry before july 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria.
  • Acción
    The firm, Baxter, sent an "Urgent Product Recall Notification" letter dated 8/18/2015 and a follow-up letter date 4/29/2016 to consignees via FedEx, overnight mail. Baxter also notified affected customers by phone. The letters described the product, problem and actions to be take. Baxter Healthcare has instructed customers to do the following: 1. Locate and remove all affected product from their facilities. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. 3. Complete the attached customer reply form and return it to Baxter by either fax it to 224-270-5457 or scanned e-mail to fca@baxter.com. 4. If you distribute this product to other facilities or departments with your institution, notify all affected parties of this communication. For general questions regarding this communication, please call Baxter's Therapeutic Medical Affairs at 805-657-0007 or 862-432-7941.
Retiro De Equipo (Recall) de Device Recall Persona" Trabecular Metal" Tibia Plate Instruments an...
  • Tipo de evento
    Recall
  • ID del evento
    74148
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1917-2016
  • Fecha de inicio del evento
    2016-05-11
  • Fecha de publicación del evento
    2016-06-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146512
  • 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, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Causa
    Zimmer inc. is initiating a recall of specific persona" trabecular metal" tibial plate instruments and modular brackets, due to incidents of radiolucent lines and loosening in implants.
  • Acción
    Zimmer Inc. is initiating a voluntary recall of Persona" Trabecular Metal" Tibia / Tibial Plate Instruments and Modular Brackets following an increase in complaints of radiolucent lines and loosening, and earlier recall of the Persona" Trabecular Metal" Tibial Plates . All sizes and lots of the affected devices are being removed from distribution. Recall notices were issued to affected distributors, hospitals, and surgeons on 05/11/2015 via mail. Customers may contact the following with any questions: 1-877-946- 2761 between 8:00 am and 5:00pm EST. Customers are asked to do the following: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist Zimmer Biomet sales representative with the quarantine of any affected product. 3. Zimmer Biomet sales representative will remove the recalled product from customer facilities. 4. Complete the Certificate of Acknowledgement Form and return to: corporatequality.postmarket@zimmerbiomet.com.
Retiro De Equipo (Recall) de Device Recall Norian Drillable Injects Sterile
  • Tipo de evento
    Recall
  • ID del evento
    74172
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1942-2016
  • Fecha de inicio del evento
    2016-05-11
  • Fecha de publicación del evento
    2016-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146594
  • 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
    Filler, bone void, calcium compound - Product Code MQV
  • Causa
    Depuy synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the norian drillable injects-sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.
  • Acción
    DePuy Synthes sent an Urgent Medical Device Recall letter dated May 9, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with the affected products were asked to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s), Complete the Verification Section (page 3 of this letter) and Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Send a copy of the completed Verification Section by:Fax: 855-695-8597 or Scan/email: Synthes6797@stericycle.com. If they had any questions they were asked to call 610-719-5450. For questions regarding this recall call 610-719-5443.
Retiro De Equipo (Recall) de Device Recall Norian Drillable Injects Sterile
  • Tipo de evento
    Recall
  • ID del evento
    74172
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1944-2016
  • Fecha de inicio del evento
    2016-05-11
  • Fecha de publicación del evento
    2016-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146596
  • 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
    Filler, bone void, calcium compound - Product Code MQV
  • Causa
    Depuy synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the norian drillable injects-sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.
  • Acción
    DePuy Synthes sent an Urgent Medical Device Recall letter dated May 9, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with the affected products were asked to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s), Complete the Verification Section (page 3 of this letter) and Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Send a copy of the completed Verification Section by:Fax: 855-695-8597 or Scan/email: Synthes6797@stericycle.com. If they had any questions they were asked to call 610-719-5450. For questions regarding this recall call 610-719-5443.
Retiro De Equipo (Recall) de Device Recall Norian Drillable Injects Sterile
  • Tipo de evento
    Recall
  • ID del evento
    74172
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1943-2016
  • Fecha de inicio del evento
    2016-05-11
  • Fecha de publicación del evento
    2016-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146595
  • 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
    Filler, bone void, calcium compound - Product Code MQV
  • Causa
    Depuy synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the norian drillable injects-sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.
  • Acción
    DePuy Synthes sent an Urgent Medical Device Recall letter dated May 9, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with the affected products were asked to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s), Complete the Verification Section (page 3 of this letter) and Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Send a copy of the completed Verification Section by:Fax: 855-695-8597 or Scan/email: Synthes6797@stericycle.com. If they had any questions they were asked to call 610-719-5450. For questions regarding this recall call 610-719-5443.
Retiro De Equipo (Recall) de Device Recall Double Pump RF Patient Cassette
  • Tipo de evento
    Recall
  • ID del evento
    74190
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2705-2016
  • Fecha de inicio del evento
    2016-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146681
  • 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
    Arthroscope - Product Code HRX
  • Causa
    Sterility of device may be compromised due to sterile package breakage.
  • Acción
    The An Urgent Field Safety Notice: Medical Device Field Safety Corrective Action / Recall letter was sent via certified mail on May 10, 2016. The letter informs customers of the issue and asks them to take the following actions: 1. Locate and quarantine affected unused devices immediately; 2. Return quarantined product to your national Smith & Nephew agency/distributor. 3. Complete the return slip and fax it to your national Smith & Nephew agency/distributor. 4. Please make sure this safety information is passed on to all those who need to be aware of it within your organization. 5. Please maintain awareness on this notice and resulting action until the Field Safety Corrective Action is terminated to ensure effectiveness of this action.
Retiro De Equipo (Recall) de Device Recall Endotine Transbleph 3.5
  • Tipo de evento
    Recall
  • ID del evento
    74222
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2294-2016
  • Fecha de inicio del evento
    2016-05-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146853
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    Microaire has initiated a limited recall (29 units)on the endotine transbleph 3.5 (cfd-080-0167), lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.E. cfd-080-0177).
  • Acción
    The firm is sending recall letters to the customers who have received the Endotine Transbleph 3.5 (CFD-080-0167), lot #285373. Letters sent by UPS to expedite the delivery.
Retiro De Equipo (Recall) de Device Recall Anatomical Shoulder" Domelock
  • Tipo de evento
    Recall
  • ID del evento
    74206
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2003-2016
  • Fecha de inicio del evento
    2016-05-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146784
  • 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, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
  • Causa
    In some cases it has been difficult or not possible to disassemble the adjusted dome centric from the as humeral rasp after initial positioning of the as humeral trial head which resulted in the whole construct of the dome centric with the still assembled as humeral rasp taken out of the humeral canal. this could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.
  • Acción
    Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL  LOT SPECIFIC notification dated May 17, 2016, to all affected consignees via courier with instructions for identifying and returning the affected product. 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. Consignees were instructed to review the notification and ensure affected personnel were aware of the contents. Assist their Zimmer Bioment sales representative with the quarantine of any affected product from the table above. Complete the Certificate of Acknowledgement Form and return to corporatequality.postmarket@zimmerbiomet.com. If after reviewing this notification consignees have further questions or concerns please call the customer call center at 1- 800-348-2759 between 8:00 am and 8:00 pm EST.
Retiro De Equipo (Recall) de Device Recall Kwire, Smooth Doublepointed 0.8 x 90mm
  • Tipo de evento
    Recall
  • ID del evento
    74224
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2084-2016
  • Fecha de inicio del evento
    2016-05-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146870
  • 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
    Passer, wire, orthopedic - Product Code HXI
  • Causa
    The affected k-wires do not meet specification requirements. specifically, a) k-wires were made of 316lvm stainless steel instead of 304 stainless steel. b) k-wires have passivated surface finish instead of electro-polish surface finish. c) k-wires have incorrect length and diameter.
  • Acción
    Integra sent an Urgent Voluntary Medical Device Recall letter dated May 20, 2016, to all affected consignees regarding the recall via traceable courier service. The letter identified the product, the problem, and the action to be taken by the customer. Customers who have supplied affected product should forward a copy of the Recall Notice to them. Customers should review their inventory for affected product, complete the form as to whether they have any affected product or not, return the form by email or fax as indicated on the form. Customers with questions should contact Customer Service at 1-800-654-2873. For questions regarding this recall call 609-936-6822.
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