Events

Recall of Device Recall Biomet Vanguard Width Checker

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
    46706
  • Event Risk Class
    Class 2
  • Event Number
    Z-1361-2008
  • Event Initiated Date
    2008-02-12
  • Event Date Posted
    2008-03-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67984
  • 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
    Template for Clinical Use - Product Code HWT
  • Reason
    The instrument's sizing line is in the wrong place.
  • Action
    Distributors were notified via Urgent Medical Device Removal Notice letter dated 2/12/08 to locate the instruments in their possession and at hospital sites and to return them to Biomet. Hospitals with the instruments on hand will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. The Puerto Rico consignee was notified by Biomet UK, Ltd. via letter on 2/26/08.

Device

Device Recall Biomet Vanguard Width Checker
  • Model / Serial
    Lot Number-212910.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide: USA, Canada, China and Finland.
  • Product Description
    Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing, Biomet Orthopedics, Inc., Warsaw, IN; The device is a preparatory instrument used for femoral knee insertion.
  • Manufacturer
    Biomet, Inc.

Manufacturer

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