Events

Rappel de Device Recall Oxford Unicompartmental Knee Phase 3 Shim Size 3

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Biomet U.K., Ltd..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    76179
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1168-2017
  • Date de mise en oeuvre de l'événement
    2016-01-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152476
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    Zimmer biomet is conducting a medical device field action for various lot-specific oxford knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. inclusions contained within the finished product could lead to the cracking and separation of the instrument.
  • Action
    Zimmer Biomet initiated a voluntary recall of the Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the ffected products by mailing letters via FedEx on 01/05/2017. Customers were instructed to Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in their 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. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form and Attachment 2  Certificate of Decontamination to Zimmer Biomet. a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com or through FAST/SMS. Be sure to specify RECALL as the RGA type. b. For each return, send a copy of Attachment 1 and Attachment 3 to corporatequality.postmarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Include a hardcopy of Attachment 2 with returned instruments. Mark the outside of the returned boxes clearly with RECALL. 5. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals that may have received or used the affected product. If there are no additional users to notify, please indicate none or NA on the form and return. 6. Retain a copy of your recall acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 7. If after reviewing the recall notice you have further questions or concerns please call the customer call center at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outs

Device

Device Recall Oxford Unicompartmental Knee Phase 3 Shim Size 3
  • Modèle / numéro de série
    Item:32-420665, Lots: ZB160601, ZB160701
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, JAPAN, NETHERLANDS
  • Description du dispositif
    Oxford Unicompartmental Knee Phase 3 Shim Size 3 || Product Usage: || Instruments for use with the Oxford Uni Partial Knee System
  • Manufacturer
    Biomet U.K., Ltd.

Manufacturer

Biomet U.K., Ltd.
  • Adresse du fabricant
    Biomet U.K., Ltd., Waterton Industrial Estate, Bridgend South Wales United Kingdom
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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