Events

Rappel de Device Recall Optilock

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
    63073
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2485-2012
  • Date de mise en oeuvre de l'événement
    2012-08-23
  • Date de publication de l'événement
    2012-09-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112459
  • 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
    Screwdriver - Product Code HXX
  • Cause
    Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw heads. drivers near mmc (maximum material condition) or that are misshapen may not properly mate with screws at mmc. design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screw.
  • Action
    Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE'' dated August 23, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. A Fax Back Response Form was included for customers to complete and return via fax to 574-372-1683. Contact the firm at 574-372-1570 for questions related to this recall.

Device

Device Recall Optilock
  • Modèle / numéro de série
    Catalog number: 14-400795; and lot numbers: 133420, 409460, 469960, 487650, 487660, 627940, 627950, 797190, and 797200.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, GA, MT, TA, AZ, WA, CA, TA, IN, NY, NJ, VA, MA, MI, MD, PA, KY, NC, UT, NH, FL, OK, CO, LA, OH, MO and SD, and the countries of Japan, Netherlands, Australia, and Costa Rica.
  • Description du dispositif
    Optilock 2.7 mm Screw Inserter. || Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone.
  • 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