Events

Recall of Device Recall OSS AVL Poly Tibial Bushing Set

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
    61100
  • Event Risk Class
    Class 2
  • Event Number
    Z-1143-2012
  • Event Initiated Date
    2012-02-07
  • Event Date Posted
    2012-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107299
  • 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
    Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Reason
    Biomet initiated this action after complaints were received where oos avl bushing sets were opened during oss knee replacement procedures, and were found to contain two tabbed bushings.
  • Action
    BIOMET Orthopedics sent an URGENT MEDICAL DEVICE recall notice dated February 7, 2012, to all affected consignees. The recall notice instructed consignees to immediate locate and remove the devices from circulation and to fax back the response form to 574-372-1683. If product was further distributed, consignees must notify hospital personnel of this action via the enclosed notice. Consignees were charged with the location and return of the affected product. For questions regarding this recall call 574-372-3983 or 574-371-3009.

Device

Device Recall OSS AVL Poly Tibial Bushing Set
  • Model / Serial
    Lot numbers861280, 294060, and 723610
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including IN. KS, NJ, CA, and OH Internationally: The Netherlands
  • Product Description
    OSS AVL Poly Tibial Bushing Set || OSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for OSS procedures.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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