Events

Rappel de Device Recall Orthopedic Manual Surgical Instrument

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
    73258
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0885-2016
  • Date de mise en oeuvre de l'événement
    2016-02-16
  • Date de publication de l'événement
    2016-02-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143636
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    A complaint was received where the hiploc plate/lag screw introducer was undersized and would not accept the introducor coupling screw. it appears now that not all parts manufactured to rev a drawing were reworked.
  • Action
    Biomet sent an " URGENT MEDICAL DEVICE RECALL NOTICE" dated February 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation. Remove the affected product from circulation. Review this notification and ensure that all affected personnel are aware of its contents. Carefully follow the instructions on the enclosed Response Form. Email a copy of the response form to CPWARFieldAction@zimmerbiomet.com prior to return of product. You do not need to complete the Biomet UK response form. Use priority carrier for your shipment. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: "Online: www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or "Call (800)FDA-1088 Thank you in advance for your assistance and prompt attention. On behalf of Zimmer Biomet, I apologize for any inconvenience this may cause. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Device

Device Recall Orthopedic Manual Surgical Instrument
  • Modèle / numéro de série
    Catalog Number: 35-000263; and Lot Number Identification: 1807188, 1807189, 1943563, and 2577847.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.
  • Description du dispositif
    HipLOC CHS Plate/Lag Screw Introducer
  • 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