Events

Recall of IMF Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet Microfixation, 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
    50516
  • Event Risk Class
    Class 2
  • Event Number
    Z-0866-2009
  • Event Initiated Date
    2008-08-06
  • Event Date Posted
    2009-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75572
  • 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
  • Reason
    Biomet microfixation is recalling the lactosorb endobrow lift complete, office fixation kit, 1.5/imf small office set and imf set trays containing instruments associated with the lactosorb and imf systems. the finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.
  • Action
    An IFU and correction letter will be issued to the field. Each distributor will receive instructions for delivering the correction letter to all customers. The customer letter will contain a reconciliation form to be returned once the customer receives the IFU for the twist drill. Contact Biomet Microfixation for additional information at 1-800-874-7711.

Device

IMF Set
  • Model / Serial
    Lot Numbers: 907650, 252341, and 300870
  • Distribution
    Distributed domestically throughout the U.S. Distributed internationally to Argentina, Australia, Canada, Columbia, Hong Kong, Japan, Mexico, New Zealand, Puerto Rico, Taiwan, Thailand, Denmark, France, Netherlands, Greece, Italy, Norway, Finland, Spain, Czech Republic, and Venezuela.
  • Product Description
    REF: 01-6871 IMF Set 254 X 127 X34MM (10"X1"X1.2") Polypropylene, Radel, AL, SS, T.C. Non Sterile Product. W.LORENZ SURGICAL, Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Reply to Post Office Box 18009 Jacksonville, Florida 32229-8009 USA 1-800-874-7711. || Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
  • Manufacturer
    Biomet Microfixation, Inc.

Manufacturer

Biomet Microfixation, Inc.
  • Manufacturer Address
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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