Events

Recall of Device Recall Biomet Orthopedics DCM AGC Molded Tibial Component

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
    44825
  • Event Risk Class
    Class 2
  • Event Number
    Z-0077-2008
  • Event Initiated Date
    2007-07-24
  • Event Date Posted
    2007-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64416
  • 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
    Incorrect product -- mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.
  • Action
    The firm notified distributor by phone on or about 7/24/07 and followed up with an Urgent Medical Device Recall Notice/Letter dated 8/31/07. The letter requested that the product be discontinued and returned to Biomet.

Device

Device Recall Biomet Orthopedics DCM AGC Molded Tibial Component
  • Model / Serial
    Lot 918930; exp. 2012-02.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Class II Recall - Worldwide Distribution --- USA including states of IA, SD, and countries of Brazil and Chile.
  • Product Description
    Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116.
  • Manufacturer
    Biomet, Inc.

Manufacturer

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