Events

Rappel de Biomet Inc., Biomet Sports Medicine, and Biomet

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, 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
    74038
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1828-2016
  • Date de mise en oeuvre de l'événement
    2016-04-01
  • Date de publication de l'événement
    2016-05-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146051
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Cause
    Insufficient seal strength on sterile barrier packaging. the seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. if the product becomes non-sterile and is used or implanted, it may lead to an infection.
  • Action
    Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 2016, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Device

Biomet Inc., Biomet Sports Medicine, and Biomet
  • Modèle / numéro de série
    Part #'s 904414 904723 904727 904754 904755 904781 904834 912029 912030 912031 912037 912046 912050 912057 912068 912069 912071 912073 912076 912077 912082 912091 916036 110003172 110003182 110005093 110005096 110005198 110005306 110005307 110016992 912036R 912036R 912037R 912040R 912141C  Lot #'s 625480 673840 763780 652380 652400 652420 652430 652440 656180 607100 563710 563720 625660 654830 654850 654870 649000 649010 649030 649040 649050 649060 649070 649080 649100 654420 654480 654490 654500 654590 654600 654610 654680 676910 676920 676930 677020 655030 530920 579450 579460 579480 579490 579500 579510 579520 579530 579540 649150 649160 655050 655100 677120 677130 677150 677160 677170 677180 649880 649930 649960 649990 677340 650010 650050 628350 677980 657260 657280 657290 722500 649490 649520 649550 649580 649600 649620 649630 655160 649830 649850 678220 678230 678260 678280 655220 664610 676800 676810 676940 676950 677480
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
  • Description du dispositif
    Various trauma and sports medicine instruments and implants. || Fastener, fixation, nondegradable, soft tissue.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Adresse du fabricant
    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