Events

Recall of COBALT CHROME MODULAR HEAD COMPONENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMET CANADA 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
    32864
  • Event Risk Class
    III
  • Event Initiated Date
    2015-05-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    An internal non-conformance discovered by biomet china reported that the gtin codes on the outer labels of various biomet orthopedics products are incorrect. there were 2 complaints describing the incorrect gtin codes.

Device

COBALT CHROME MODULAR HEAD COMPONENT
  • Model / Serial
    Model Catalog: 163668 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 163667 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 163669 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 163670 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 11-104211 (Lot serial: 349650); Model Catalog: 11-104212 (Lot serial: 182030); Model Catalog: 11-104211 (Lot serial: 182030); Model Catalog: 11-104212 (Lot serial: 127340); Model Catalog: 11-104211 (Lot serial: 127340); Model Catalog: 11-104212 (Lot serial: 349650); Model Catalog: 141316 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 141318 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 141320 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 141314 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 163674 (Lot serial: 453220); Model Catalog: 113644 (Lot serial: NA)
  • Product Description
    BIOMET HIP SYSTEM MODULAR HEAD COMPONENT-STANDARD
  • Manufacturer
    BIOMET CANADA INC.

Manufacturer

BIOMET CANADA INC.
  • Manufacturer Address
    OAKVILLE
  • 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
    HC