Events

Recall of Biomet RINGLOC Instrumentation Impactor Plate

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
    45987
  • Event Risk Class
    Class 2
  • Event Number
    Z-0704-2008
  • Event Initiated Date
    2007-10-18
  • Event Date Posted
    2008-02-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66625
  • 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
    Acetabular Inserter Instrument - Product Code LXH
  • Reason
    The instrument will not lock onto the impactor handle; the device was distributed without assembly of the bal seal component.
  • Action
    Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations.

Device

Biomet RINGLOC Instrumentation Impactor Plate
  • Model / Serial
    Lot Number: 038710.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.
  • Product Description
    Biomet RINGLOC + Instrumentation Impactor Plate, Size 26; REF/Part#: 31-400626, Biomet Orthopedics, Inc., Warsaw, IN.
  • Manufacturer
    Biomet, Inc.

Manufacturer

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