Events

Rappel de Device Recall Oxford Unicompartmental Toffee Hammer

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
    64679
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1124-2013
  • Date de mise en oeuvre de l'événement
    2013-03-20
  • Date de publication de l'événement
    2013-04-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-05-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116755
  • 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
    Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
  • Cause
    Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could lead to part of the head becoming detached from the handle.
  • Action
    BIOMET sent an Urgent Medical Device Recall Notice on March 20, 2013, to all affected customers with directions to forward the notice if product was further distributed to Hospital Operating Room managers. The notice identified the recalled device, reason for the recall, and possible adverse events directing consignees to locate and discontinue use of the device. A FAX back Response form was to be returned to 574-372-1683 within 3 days of receipt prior to return of the product to Biomet, USA. Questionsregarding this recall should be addressed to 574 372-1570 M-F, 8a.m. -5 p.m.

Device

Device Recall Oxford Unicompartmental Toffee Hammer
  • Modèle / numéro de série
    32-422760 ( sold as part of instrument set 32-422763 ) ZB100901,ZB110201,ZB110301,ZB110302,ZB110303, ZB110304,ZB110601,ZB110602,ZB110701,ZB111201, ZB111202,ZB120201,ZB120202,ZB120701,ZB120801, ZB120802,ZB121102,ZB121103
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica.
  • Description du dispositif
    REF 32-422760 || Oxford Uni Knee System,Toffee Hammer, non-sterile, || found in REF 32-422763 Oxford Mlcroplasty Knee System || Tibial instrument Tray || small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants.
  • 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