Events

Rappel de Device Recall Zimmer M/L Taper Hip Prosthesis

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 Biomet, 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
    73298
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1046-2016
  • Date de mise en oeuvre de l'événement
    2016-02-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143788
  • 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, porous uncemented - Product Code LPH
  • Cause
    Zimmer biomet initiated a lot-specific voluntary recall on 02/11/2016, of the m/l taper hip prosthesis. single manufacturing lot of size 12.5, extended offset, m/l taper hip stems was incorrectly etched. the device was etched as std, rather than ext. the product packaging is labeled correctly as extended. offset, and the device is an extended offset stem.
  • Action
    Zimmer, Inc. initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. Electronic notices were e-mailed to distributors, and letters were mailed via certified mail on 02/11/2016 to distributors and hospitals. A field complaint investigation confirmed that this single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended Offset, and the device is an extended offset stem. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: Assisting the Zimmer Biomet sales representative with the quarantine of the product and completion and return of the Acknowledgement Form. Customers are asked to complete the Certificate of Acknowledgement Form and return to corporatequality.postmarket@zimmerbiomet.com. Customers with have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST.

Device

Device Recall Zimmer M/L Taper Hip Prosthesis
  • Modèle / numéro de série
    Item: 00-7711-012-20, Lot: 62937093
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.
  • Description du dispositif
    M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Adresse du fabricant
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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