Events

Recall of 45mm Left Standard Offset Mandible

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
    60910
  • Event Risk Class
    Class 2
  • Event Number
    Z-0823-2012
  • Event Initiated Date
    2010-04-07
  • Event Date Posted
    2012-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106771
  • 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
    Mandibular condyle prosthesis - Product Code MPL
  • Reason
    Biomet microfixation, inc., jacksonville, fl recalled part # 24-6546, 45mm left standard mandible and part # 24-6646, 45mm left standard offset mandible due to a lot of 24-6246 being etched & labeled as 24-6646 and the reverse, a lot of 24-6646 being etched and labeled as 24-6546.
  • Action
    Biomet Microfixation Inc sent an URGENT-Medical Device Recall notice to all consignees. The letter informs the customers to discontinue use of the items and return them to Biomet Microfixation.They also ask all customers to complete the inventory reconciliation sheet and return it by fax to the Global Complaint Coordinator. The letter also states that if the product was further distributed, the letter must be forwarded on to the firm's customers. For questions call 1-800-874-7711 or 904-741-4400, ext 468.

Device

45mm Left Standard Offset Mandible
  • Model / Serial
    Product Part # 24-6646, lot # 080300
  • Product Classification
    Dental Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) in the state of Florida and in the countries Germany and Guatemala.
  • Product Description
    The 45mm Left Standard Offset Mandible is one component in the Total Temporomandibular Joint (TMJ) Replacement System used to functionally reconstruct a diseased and/or damaged temporomandibular joint. || The component is labeled in part: "REF: 24-6646***TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT***QTY 00001***45MM / 7 HOLE CO-CR-MO, TI-6AL-4V ALLOY***BIOMET MICROFIXATION 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com*** || Product Recall: The Total Temporomandibular Joint (TMJ) Replacement System is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ Replacement System is a two-component system comprised of mandibular condyle and glenoid fossa components. Both components are available in multiple sizes as right and left side specific designs and are attached to bone by screws. Mandibular (Condylar) Prosthesis- The prosthesis is designed to replace the articular surface of the mandibular condyle. The mandibular prosthesis is offered in 3 different sizes: 45mm, 50mm, and 55mm, designated left and right. The mandibular prosthesis is offered in 3 styles:Standard, Offset, and Narrow, to fit a diverse range of mandibular sizes and shapes. The mandibular prosthesis is made of Cobalt Chromium Alloy. The under-surface of the prosthesis is coated with titanium plasma spray for increased bony integration to the mandibular prosthesis.
  • 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