Events

Rappel de Zimmer

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 Zimmer Trabecular Metal Technology, Inc..

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
    73536
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1954-2016
  • Date de mise en oeuvre de l'événement
    2016-04-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-11-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145920
  • 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, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • Cause
    Zimmer biomet is initiating a recall of specific lots of foil pouched, sterile trabecular metal implants that were manufactured between april 2011 and october 2012. the foil pouches are part of a dual barrier system to provide sterile integrity.
  • Action
    Zimmer issued an Urgent Medical Device Recall Letter dated 4/15/2016.

Device

Zimmer
  • Modèle / numéro de série
    00700504828 REV. SHELL LINER 0D 28X48 62192382 61924517 61979224 62102328 00701005028 REV. SHELL LINER 10D 28X50 61787378 61979209 62165315 62188095 00701005228 REV. SHELL LINER 10D 28X52 61979218 00701005428 REV. SHELL LINER 10D 28X54 61787382 62077039 00701005628 REV. SHELL LINER 10D 28X56 61799041 61976886 62165323 62188094 00701005828 REV. SHELL LINER 10D 28X58 61886620 62103434 00701006028 REV. SHELL LINER 10D 28X60 61979220 61979221 62077046 00701006228 REV. SHELL LINER 10D 28X62 61986244 62101503 62192380 00701006628 REV. SHELL LINE 10D 28X66 61787381 61979212 62042739 62042740 00702004828 REV. SHELL LINER 20D 28X48 61987076 00702005028 REV. SHELL LINER 20D 28X50 61987075 00702005228 REV. SHELL LINER 20D 28X52 62102429 00702005428 REV. SHELL LINER 20D 28X54 62103435 00702005628 REV. SHELL LINER 20D 28X56 61964049 62029515 62077034 62102329 00702006028 REV. SHELL LINER 20D 28X60 61787385 61853155 00702006228 REV. SHELL LINER 20D 28X62 61915568 61979214 62102867 00702006628 REV. SHELL LINER 20D 28X66 61787383 61787384 62102865
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide and Foreign.
  • Description du dispositif
    REV. SHELL LINER 0D 28X48 00700504828 || REV. SHELL LINER 10D 28X50 00701005028 || REV. SHELL LINER 10D 28X52 00701005228 || REV. SHELL LINER 10D 28X54 00701005428 || REV. SHELL LINER 10D 28X56 00701005628 || REV. SHELL LINER 10D 28X58 00701005828 || REV. SHELL LINER 10D 28X60 00701006028 || REV. SHELL LINER 10D 28X62 00701006228 || REV. SHELL LINE 10D 28X66 00701006628 || REV. SHELL LINER 20D 28X48 00702004828 || REV. SHELL LINER 20D 28X50 00702005028 || REV. SHELL LINER 20D 28X52 00702005228 || REV. SHELL LINER 20D 28X54 00702005428 || REV. SHELL LINER 20D 28X56 00702005628 || REV. SHELL LINER 20D 28X60 00702006028 || REV. SHELL LINER 20D 28X62 00702006228 || REV. SHELL LINER 20D 28X66 00702006628
  • Manufacturer
    Zimmer Trabecular Metal Technology, Inc.

Manufacturer

Zimmer Trabecular Metal Technology, Inc.
  • Adresse du fabricant
    Zimmer Trabecular Metal Technology, Inc., 10 Pomeroy Rd, Parsippany NJ 07054-3722
  • 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