Events

Recall of Biomet 8.0MM cannulated reamer for the Aimer system

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
    52885
  • Event Risk Class
    Class 2
  • Event Number
    Z-2042-2009
  • Event Initiated Date
    2009-08-06
  • Event Date Posted
    2009-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84221
  • 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
    Orthopedic Surgical Instrument Ac-Powered Motor and Accessories/Attachments - Product Code HWE
  • Reason
    These surgical instruments are etched with incorrect measurement markings.
  • Action
    Consignees were notified by letter dated 8/6/09 to remove the instrument from use and to return the recalled instrument to Biomet. Implanting surgeons were notified by letter dated 8/6/09, advised of the problem and it was suggested that the patients be monitored for instability if deemed necessary by the surgeon.

Device

Biomet 8.0MM cannulated reamer for the Aimer system
  • Model / Serial
    Lot 027410.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- Including the state of Texas.
  • Product Description
    Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA; REF 909618.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA