Events

Rappel de Device Recall Comprehensive Shoulder System

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
    79385
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0979-2018
  • Date de mise en oeuvre de l'événement
    2017-12-08
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162189
  • 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, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
  • Cause
    Zimmer biomet is conducting a medical device recall for two lots of comprehensive humeral stems. the lots were commingled during the manufacturing process and were etched with incorrect lot numbers. the size difference between the two stem sizes is 1.1 inches. it is visually recognizable by the user that the box label does not match the contents of the box.
  • Action
    On December 13, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers notifying them of the mix-up and requesting that they review the notification, discuss with team members, see if any product is in inventory and if so, quarantine and discontinue use. Affected product should be returned to the recalling firm. Questions or concerns can be directed to customer service at 574-371-3071.

Device

Device Recall Comprehensive Shoulder System
  • Modèle / numéro de série
    PN: 113633, LN: 421700, UDI# - (01) 00880304462632 (17) 271014 (10) 421700
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide in the states of MN, NJ, CA, TX, ND
  • Description du dispositif
    Humeral Stem 83mm(Size 17) || Product Usage: || Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Adresse du fabricant
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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