Events

Recall of Device Recall Biomet CC Cruciate Tibial Tray

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
    46141
  • Event Risk Class
    Class 2
  • Event Number
    Z-0707-2008
  • Event Initiated Date
    2007-12-12
  • Event Date Posted
    2008-01-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66960
  • 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
    Tibial Tray - Product Code JWH
  • Reason
    Mislabeled as to size: package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.
  • Action
    Consignees were notified via an Urgent Medical Device Recall Notice dated 12/12/07 to cease use of the product and to return it.

Device

Device Recall Biomet CC Cruciate Tibial Tray
  • Model / Serial
    Lot Number: 448740.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide: USA including states of Georgia, Idaho, Indiana, Missouri, Ohio, and Virginia and country of Turkey.
  • Product Description
    Biomet CC Cruciate Tibial Tray, 75 mm.; Product No. 141234, Biomet, Inc., Warsaw, IN 46581
  • Manufacturer
    Biomet, Inc.

Manufacturer

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