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  • Dispositivo 42
  • Fabricante 18
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall Phantom Fiber Biofiber Sutures
  • Tipo de evento
    Recall
  • ID del evento
    79373
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1374-2018
  • Fecha de inicio del evento
    2018-02-08
  • 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=162146
  • 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
    Suture, recombinant technology - Product Code NWJ
  • Causa
    Data has shown that degradation of a raw material used in phantom fiber may occur more quickly than expected if improperly stored. this may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected.
  • Acción
    The firm, Wright, sent an "Urgent Field Safety Notice" letter by email on 02/08/2018. The firm followed up with a letter on April 02, 2018 disseminated by FedEx Priority mail to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following actions: " Cease using the affected devices immediately. " Medical facilities are to determine if any of the recalled implants are on hand, and return affected implants immediately to Wright Medical. "Review the notice and complete the Acknowledgement Section Attachment C to signify that your facility has been informed of this Field Safety Notice (Recall). " Return the completed Acknowledgement to Wright Medical via email to: FieldAction@wright.com within five (5) working days of this notice. "Contact customer service at 1-888-494-7950 to facilitate any product returns. For any inquiries regarding the Phantom Fiber Field Safety Notice (Recall) contact: Wright Medical Quality Systems Manager by Email: FieldAction@wright.com or Phone: 952.683.7482.
Retiro De Equipo (Recall) de Device Recall The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser
  • Tipo de evento
    Recall
  • ID del evento
    79379
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1272-2018
  • Fecha de inicio del evento
    2018-01-21
  • 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=162149
  • 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
    Ophthalmic femtosecond laser - Product Code OOE
  • Causa
    This correction is being initiated based on a customer complaint received on november 16, 2017 which indicated a complication with a cataract procedure. an investigation completed by the manufacturer determined that although the complication was due to user error improvements could and should be made on our part to improve the usability and performance of our device.
  • Acción
    The firm, Ziemer Ophthalmology, initiated their field correction by telephone on 01/21/2018 and followed with a letter on 01/28/2018. The letter described the product, problem and actions taken. The letter stated: "...we will be releasing new software which contains an added safety feature which will prevent unintended shift of the planned ARC Incisions and/or alert you in case of unforeseen eye movement between configuration and execution of the ARC incisions. We will be contacting your practice the week of March 12th to set up a time to install this new software and provide in-depth training. Prior to the installation of the new software, you may continue to use the Z8 for cataract surgery; however, we would advise that you not perform both arcuate and clear corneal incisions on the same patient until the new software is installed. If you have any questions, do not hesitate to contact Director of Operations at 618-462-9301 for any further information you require.
Retiro De Equipo (Recall) de Device Recall NovaKone
  • Tipo de evento
    Recall
  • ID del evento
    79377
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0981-2018
  • Fecha de inicio del evento
    2017-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162150
  • 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
    Lenses, soft contact, daily wear - Product Code LPL
  • Causa
    Contact lenses lack sterility assurance.
  • Acción
    Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
Retiro De Equipo (Recall) de Device Recall NovaKone
  • Tipo de evento
    Recall
  • ID del evento
    79377
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0982-2018
  • Fecha de inicio del evento
    2017-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162151
  • 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
    Lenses, soft contact, daily wear - Product Code LPL
  • Causa
    Contact lenses lack sterility assurance.
  • Acción
    Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
Retiro De Equipo (Recall) de Device Recall Alden Classic 38
  • Tipo de evento
    Recall
  • ID del evento
    79377
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0983-2018
  • Fecha de inicio del evento
    2017-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162152
  • 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
    Lenses, soft contact, daily wear - Product Code LPL
  • Causa
    Contact lenses lack sterility assurance.
  • Acción
    Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
Retiro De Equipo (Recall) de Device Recall Alden HP49
  • Tipo de evento
    Recall
  • ID del evento
    79377
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0984-2018
  • Fecha de inicio del evento
    2017-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162153
  • 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
    Lenses, soft contact, daily wear - Product Code LPL
  • Causa
    Contact lenses lack sterility assurance.
  • Acción
    Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
Retiro De Equipo (Recall) de Device Recall Alden HP59
  • Tipo de evento
    Recall
  • ID del evento
    79377
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0986-2018
  • Fecha de inicio del evento
    2017-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162155
  • 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
    Lenses, soft contact, daily wear - Product Code LPL
  • Causa
    Contact lenses lack sterility assurance.
  • Acción
    Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
Retiro De Equipo (Recall) de Device Recall Alden HP49
  • Tipo de evento
    Recall
  • ID del evento
    79377
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0987-2018
  • Fecha de inicio del evento
    2017-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162156
  • 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
    Lenses, soft contact, daily wear - Product Code LPL
  • Causa
    Contact lenses lack sterility assurance.
  • Acción
    Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
Retiro De Equipo (Recall) de Device Recall Alden HP54
  • Tipo de evento
    Recall
  • ID del evento
    79377
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0988-2018
  • Fecha de inicio del evento
    2017-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162157
  • 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
    Lenses, soft contact, daily wear - Product Code LPL
  • Causa
    Contact lenses lack sterility assurance.
  • Acción
    Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
Retiro De Equipo (Recall) de Device Recall Alden Classic 55
  • Tipo de evento
    Recall
  • ID del evento
    79377
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0989-2018
  • Fecha de inicio del evento
    2017-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162158
  • 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
    Lenses, soft contact, daily wear - Product Code LPL
  • Causa
    Contact lenses lack sterility assurance.
  • Acción
    Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
Retiro De Equipo (Recall) de Device Recall Belzer UW & Waters IGL Cold Storage Solution
  • Tipo de evento
    Recall
  • ID del evento
    79378
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1387-2018
  • Fecha de inicio del evento
    2018-02-26
  • 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=162159
  • 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
    System, perfusion, kidney - Product Code KDN
  • Causa
    Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag.
  • Acción
    An Urgent: Product Recall Notification letters, dated February 26, 2018, were sent to consignees. The instructions include, halting distribution of any 2 Liter bags in inventory; and, arranging for the return of affected units. Preservation Solutions, Inc. provided a notification letter for their consignees to provide to their customers. The letter instructed customers to return any 2 Liter bags to their supplier, and to complete and return the acknowledgement form.
Retiro De Equipo (Recall) de Device Recall Alden HP59
  • Tipo de evento
    Recall
  • ID del evento
    79377
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0990-2018
  • Fecha de inicio del evento
    2017-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162160
  • 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
    Lenses, soft contact, daily wear - Product Code LPL
  • Causa
    Contact lenses lack sterility assurance.
  • Acción
    Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
Retiro De Equipo (Recall) de Device Recall NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL ...
  • Tipo de evento
    Recall
  • ID del evento
    78706
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1049-2018
  • Fecha de inicio del evento
    2017-11-29
  • 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=162408
  • 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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
  • Acción
    A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag. A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. Distributor Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 4. Return the Additi
Retiro De Equipo (Recall) de Device Recall ASTERA
  • Tipo de evento
    Recall
  • ID del evento
    79377
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0991-2018
  • Fecha de inicio del evento
    2017-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162161
  • 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
    Lenses, soft contact, daily wear - Product Code LPL
  • Causa
    Contact lenses lack sterility assurance.
  • Acción
    Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
Retiro De Equipo (Recall) de Device Recall SporAmpule Biological Indicator
  • Tipo de evento
    Recall
  • ID del evento
    79374
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1274-2018
  • Fecha de inicio del evento
    2018-02-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162162
  • 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
    Indicator, biological sterilization process - Product Code FRC
  • Causa
    The concentration of bromocresol purple in the recalled lots does not conform to specification.
  • Acción
    Per the Recall Strategy, consignees have been requested to immediately discontinue use and discard according to site procedures.
Retiro De Equipo (Recall) de Device Recall QUANTALyser 240 IFA
  • Tipo de evento
    Recall
  • ID del evento
    79380
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1221-2018
  • Fecha de inicio del evento
    2018-01-26
  • Estado del evento
    Terminated
  • 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=162171
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
  • Acción
    The letters were issued via email on January 26, 2018, informing the consignee of the issue and the actions to be taken. The response forms were requested to be completed and returned by February 23, 2018, indicating receipt of the notification and confirmation that the power supply has been replaced. The firm reported on February 23, 2018 that responses have been received from both consignees. For further questions, please call (858) 586-9900 x 1381.
Retiro De Equipo (Recall) de Device Recall QUANTALyser 240 EIA
  • Tipo de evento
    Recall
  • ID del evento
    79380
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1222-2018
  • Fecha de inicio del evento
    2018-01-26
  • Estado del evento
    Terminated
  • 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=162184
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
  • Acción
    The letters were issued via email on January 26, 2018, informing the consignee of the issue and the actions to be taken. The response forms were requested to be completed and returned by February 23, 2018, indicating receipt of the notification and confirmation that the power supply has been replaced. The firm reported on February 23, 2018 that responses have been received from both consignees. For further questions, please call (858) 586-9900 x 1381.
Retiro De Equipo (Recall) de Device Recall AQUIOS CL Flow Cytometer System, Catalog B30166
  • Tipo de evento
    Recall
  • ID del evento
    79381
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1341-2018
  • Fecha de inicio del evento
    2018-01-29
  • 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=162185
  • 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
    Flow cytometric reagents and accessories. - Product Code OYE
  • Causa
    The device may process the same sample with two different sample ids and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification.
  • Acción
    The recalling firm issued letters dated 1/25/2018 via email on 1/31/2018 or to some customers via regular mail during the week of 1/29/2018.
Retiro De Equipo (Recall) de Device Recall Persona Partial Knee
  • Tipo de evento
    Recall
  • ID del evento
    79383
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1238-2018
  • Fecha de inicio del evento
    2017-11-29
  • 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=162188
  • 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, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
  • Causa
    Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
  • Acción
    Zimmer Biomet sent an Urgent Medical Device Correction Recall letter dated November 29, 2017. RISK MANAGER PHASE I: 1. Review this notification and notify affected personnel of the contents. 2. Product does not need to be returned at this time. You will receive a follow-up notice when the removal phase is initiated (Phase 2). If you identify a spacer block that will not assemble with these instruments, and you are unwilling to use the spacer block without this functionality, the spacer block may be returned to your sales representative. 3. Complete Certificate of Acknowledgement (Phase 1) and send to CorporateQuality.PostMarket@zimmerbiomet.com. SURGEON PHASE I: 1. Review this notification for awareness of the contents. 2. The spacer block may be used without the alignment tower and inserted and removed by hand from the joint, without the Persona Partial Knee handle. If you identify a spacer block that will not assemble with these instruments, and you are unwilling to use the spacer block without this functionality, the spacer block may be returned to your sales representative. 3. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 4. Complete Certificate of Acknowledgement (Phase 1) and send to CorporateQuality.PostMarket@zimmerbiomet.com. DISTRIBUTOR PHASE I: 1. Review this notification and notify affected team of the contents. 2. Product does not need to be returned at this time. You will receive a follow-up notice when the removal phase is initiated. 3. Should you or your account prefer to perform a functional check, this may be done by using the instructions in the surgical technique for assembling the alignment tower and handle to the spacer block. If you or your account identify a spacer block that will not assemble with these instruments, and the user is unwilling to use the spacer block without this functionality, the spacer block may be returned as a complaint to Pr
Retiro De Equipo (Recall) de Device Recall Comprehensive Shoulder System
  • Tipo de evento
    Recall
  • ID del evento
    79385
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0979-2018
  • Fecha de inicio del evento
    2017-12-08
  • 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=162189
  • 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, hemi-, humeral, metallic uncemented - Product Code HSD
  • Causa
    Zimmer biomet is conducting a medical device recall for two lots of comprehensive humeral stems. the lots were commingled during the manufacturing process and were etched with incorrect lot numbers. the size difference between the two stem sizes is 1.1 inches. it is visually recognizable by the user that the box label does not match the contents of the box.
  • Acción
    On December 13, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers notifying them of the mix-up and requesting that they review the notification, discuss with team members, see if any product is in inventory and if so, quarantine and discontinue use. Affected product should be returned to the recalling firm. Questions or concerns can be directed to customer service at 574-371-3071.
Retiro De Equipo (Recall) de Device Recall Comprehensive Shoulder System
  • Tipo de evento
    Recall
  • ID del evento
    79385
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0980-2018
  • Fecha de inicio del evento
    2017-12-08
  • 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=162190
  • 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, hemi-, humeral, metallic uncemented - Product Code HSD
  • Causa
    Zimmer biomet is conducting a medical device recall for two lots of comprehensive humeral stems. the lots were commingled during the manufacturing process and were etched with incorrect lot numbers. the size difference between the two stem sizes is 1.1 inches. it is visually recognizable by the user that the box label does not match the contents of the box.
  • Acción
    On December 13, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers notifying them of the mix-up and requesting that they review the notification, discuss with team members, see if any product is in inventory and if so, quarantine and discontinue use. Affected product should be returned to the recalling firm. Questions or concerns can be directed to customer service at 574-371-3071.
Retiro De Equipo (Recall) de Device Recall Laser Indirect Ophthalmoscope (LIO) .
  • Tipo de evento
    Recall
  • ID del evento
    79386
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1075-2018
  • Fecha de inicio del evento
    2018-02-27
  • 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=162191
  • 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
    It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
  • Acción
    Action Taken by IRIDEX: 1. A investigation was started immediately upon receipt of the returned devices from the Sloan Kettering complaint on November 3, 2017. CAPA 0125 was initiated to document the events, root cause, correction, corrective and preventive action and effectiveness of these actions. 2. A ship hold was initiated on November 15, 2017. 3.As described below, IRIDEX plans to notify customers and distributors that it is voluntarily recalling all models of the TruFocus LIO Premiere. 4. Public Warning A press release was prepared and sent out on February 23, 2018. For further questions please call (650) 962-8848 Ext. 3672
Retiro De Equipo (Recall) de Device Recall Cannulated Screw System
  • Tipo de evento
    Recall
  • ID del evento
    79387
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1064-2018
  • Fecha de inicio del evento
    2017-12-07
  • 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=162192
  • 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
    One lot of 3.5mm x 24mm cortical locking screws is labeled as 6.5mm x 125mm x 16mm cannulated screws.
  • Acción
    Zimmer Biomet sent an Urgent Medical Device Recall letter dated December 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Review this notification n and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. Request an International Return Authorization Number by emailing zimmerbiometintlirarequests@zimmerbiomet.com c. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. d. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. e. Mark "RECALL" on the outside of the returned cartons. 4. Return a copy of the your Inventory Return Certification and product return form. 5. For questions call customer service at 574-374-3071.
Retiro De Equipo (Recall) de Device Recall PERSONA THE PERSONALIZED KNEE SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    79394
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1224-2018
  • Fecha de inicio del evento
    2017-12-12
  • 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=162203
  • 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
    U.V. Method, cpk isoenzymes - Product Code JHW
  • Causa
    A complaint was received for item 42-5320-067-02, lot 63236047. it was report that there was no set screw or taper plug included in the box. complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.
  • Acción
    On December 12, 2017 an URGENT MEDICAL DEVICE RECALL LETTER was issued to customers will the following guidance: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. Questions or concerns can be directed to 1-574-371-3071.
Retiro De Equipo (Recall) de Device Recall SwishTapered Implant
  • Tipo de evento
    Recall
  • ID del evento
    79396
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1167-2018
  • Fecha de inicio del evento
    2018-01-19
  • 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=162206
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • Causa
    The extender that is packaged with the swishtapered" and swishplus" implant may have been packaged in the incorrect position (upside down in the plastic retainer).
  • Acción
    Customers were sent Urgent: Safety Alert/Advisory Notice letters around 01/19/2018. The Notice identified the affected device and the reason for the correction. Instructions for both distributors and doctors include to review inventory for affected product, complete and return the Acknowledgement form within 48 hours of receipt of the letter, follow the included instructions to correct the affected product, and distributors are to notify those customers that may have been shipped the affected product lot and inform them of the issue. Questions should be directed to Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
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