Events

Recall of MAGNA-FX CANNULATED SCREW FIXATION SYSTEM AND INSTRUMENTATION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ZIMMER 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
    32878
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-06
  • 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
    These screws are packaged with a double barrier system two plastic trays and two tyvek lids to provide sterile integrity. process monitoring conducted as part of the standard packaging process identified that in some instances a small hole may be present in the inner tray. the holes were found to be caused by a single tool used by the tray supplier in the manufacturing process and estimated to be present in less than 10% of the affected devices. the outer tray is not affected and the device's sterile integrity remains until the outer tray is opened. no product complaints have been reported for this issue.

Device

MAGNA-FX CANNULATED SCREW FIXATION SYSTEM AND INSTRUMENTATION
  • Model / Serial
    Model Catalog: 00114205130 (Lot serial: 63296605); Model Catalog: 00114606532 (Lot serial: 63290146); Model Catalog: 00114606099 (Lot serial: 63290146); Model Catalog: 00114205138 (Lot serial: 63290146); Model Catalog: 00114205124 (Lot serial: 63290146); Model Catalog: 00114205130 (Lot serial: 63290146); Model Catalog: 00114606532 (Lot serial: 63290143); Model Catalog: 00114606099 (Lot serial: 63290143); Model Catalog: 00114205138 (Lot serial: 63290143); Model Catalog: 00114205124 (Lot serial: 63290143); Model Catalog: 00114205130 (Lot serial: 63290143); Model Catalog: 00114606532 (Lot serial: 63303825); Model Catalog: 00114606099 (Lot serial: 63303825); Model Catalog: 00114205138 (Lot serial: 63303825); Model Catalog: 00114205124 (Lot serial: 63303825); Model Catalog: 00114205130 (Lot serial: 63303825); Model Catalog: 00114606532 (Lot serial: 63308562); Model Catalog: 00114606099 (Lot serial: 63308562); Model Catalog: 00114205138 (Lot serial: 63308562); Model Catalog: 00114205124 (Lot serial: 63296605); Mod
  • Product Description
    MAGNA-FX CANNULATED SCREW FIXATION SYSTEM AND INSTRUMENTATION;COMPRESSION SCREW;TRILOGY ACETABULAR SYSTEM-BONE SCREWS
  • Manufacturer
    ZIMMER BIOMET CANADA INC.

Manufacturer

ZIMMER BIOMET CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • 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