Events

Recall of Device Recall lactoscrew

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
    34021
  • Event Risk Class
    Class 3
  • Event Number
    Z-0329-06
  • Event Initiated Date
    2005-11-10
  • Event Date Posted
    2005-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42920
  • 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
    Bit, Surgical - Product Code GFG
  • Reason
    The bit may bend or fracture during use.
  • Action
    Consignees were notified to return the product via letter dated 11/10/05.

Device

Device Recall lactoscrew
  • Model / Serial
    Lots 044250, 134170, 781690, 781700, 838920, 914620 and 914630.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Belgium, Columbia, Finland, Israel, Poland and United Kingdom.
  • Product Description
    Arthrotek brand Lactoscrew instruments 3.5 mm drill bit, stainless steel; ref. 905585.
  • Manufacturer
    Biomet, Inc.

Manufacturer

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