Events

Recall of Device Recall Biomet Vanguard DCM CR Tibial Bearing

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    46708
  • Event Risk Class
    Class 2
  • Event Number
    Z-1376-2008
  • Event Initiated Date
    2008-02-12
  • Event Date Posted
    2008-07-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67991
  • Notes / Alerts
    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.
  • Extra notes in the data
    Knee Prosthesis - Product Code JWH
  • Reason
    Mislabeled: the packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. if implanted, the product may not fit properly, which could require repeat surgery. the problem could also result in a delay in the procedure.
  • Action
    Distributors were notified via recall letter (Urgent Medical Device Removal Notice) dated 2/12/08 to locate the devices in their possession and at hospital sites, discontinue use, and return them to Biomet. Hospitals having received the devices will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. A third letter dated 2/12/08 was provided for implanting physicians.

Device

Device Recall Biomet Vanguard DCM CR Tibial Bearing
  • Model / Serial
    Lot 743470.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide: USA and Australia
  • Product Description
    Biomet Vanguard DCM CR Tibial Bearing, 14MM x 79/83MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183464.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46581-0587
  • Source
    USFDA