Events

Recall of Biomet Signature " TKA GDE/MDL SET 0405

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
    59740
  • Event Risk Class
    Class 2
  • Event Number
    Z-1145-2012
  • Event Initiated Date
    2011-08-04
  • Event Date Posted
    2012-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103533
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    Biomet has initiated this action following investigation that identified two (2) specific lots of part number 42-422561 were incorrectly labeled. one (1) unit (lot 025640) was received back from distributor's office as a product complaint.
  • Action
    The firm, BIOMET Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated January 23, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: -Immediately locate and remove the above identified Signature " Guide and Model Set. -Carefully follow the instructions on the enclosed FAX Back Response Form. - Fax a copy of the Response Form to 574-372-1683 prior to return of product. - Use priority carrier for your shipment. - If you have further distributed this product, you MUST notify hospital personnel of this action, via the enclosed recall letter. This letter MUST be given to hospital personnel responsible for receiving recall notices. Confirm receipt of this notice by calling, 800-348-9500, extension 3983. Questions related to this notice should be directed to 574-372-3983, Monday through Friday, 8AM to 5PM.

Device

Biomet Signature " TKA GDE/MDL SET 0405
  • Model / Serial
    Catalog number 42-422561 Lot numbers: 025565 & 025640
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution:Virginia and Ohio only.
  • Product Description
    REF 42-422561 SIGNATURE QTY, 1 TKA GDE/MDL (Prosthesis, knee) SET 04-05 DGHUMPHR-NOV52LKA-J_K-00432022 SLIDEX DISTAL-MP/PREMIER TIBIAL CUSTOM-MADE DEVICE || Signature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in the guiding and marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
  • 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