Events

Retiro De Equipo (Recall) de Device Recall various polyethylene implants

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Zimmer Biomet, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    76507
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1859-2017
  • Fecha de inicio del evento
    2017-02-17
  • Fecha de publicación del evento
    2017-03-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-01-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154239
  • 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
    Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
  • Acción
    On February 17, 2017 URGENT MEDICAL DEVICE RECALL (REMOVAL) - LOT SPECIFIC notifications were sent to the affected consignees 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. Distributors, Sales Representatives, and Distributor Operation Managers Your Responsibilities: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet within 2 weeks. a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com or through FAST/SMS. Specify RECALL as the RGA type. b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Clearly mark RECALL on the outside of return boxes. 5. Hospitals that received direct shipments of the affected products from Zimmer Biomet will be sent a copy of the Risk Manager Recall Notice directly. Surgeons will also be notified. It is important that you review the list of hospitals and surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice, return contact information for any additional hospitals and surgeons that may have received or used the affected product. If there are no additional

Device

Device Recall various polyethylene implants
  • Modelo / Serial
    Items and lots: Item 113870 361800 Item 113951 605610 684300 684310 684320 684330 684340 Item 113952 174480 241520 292440 292480 372590 372600 372610 372620 372630 372640 596930 596940 596950 596960 605640 605650 605670 Item 113954 174560 241500 270220 270230 292490 292510 292520 292560 292570 372650 372660 372670 372680 372700 372710 596970 596980 596990 605680 605690 605700 605710 707650 Item 113956 292580 292590 292640 605720 605730 605740 Item 114827 804070 Item EP-115393 488700 488710 577700 577710 667420 667430 667460 Item EP-115394 488750 577740 Item EP-115395 577760 Item EP-115396 488760 577770 Item EP-115398 832600 Item PM555411 430360 Item XL-115363 169490 179400 488780 488790 488810 488830 488850 488870 488890 488900 488910 488920 515590 560180 560210 667480 667490 667500 667510 744780 744810 773080 Item XL-115364 542280 542290 744850 744870 Item XL-115366 502530 502540 502560 614450 666000 Item XL-115367 630520
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK
  • Descripción del producto
    various polyethylene implants || Extremities, Shoulders and Elbows || BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System || Product Usage: || Shoulder Replacement Elbow Replacement
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Dirección del fabricante
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA