Events

Recall of ZMR HIP SYSTEM - FEMORAL STEMS - POROUS STEMS

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
    147422
  • Event Risk Class
    I
  • Event Initiated Date
    2011-10-27
  • 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
    This action is being conducted for a labeling correction of the zmr porous revision hip prosthesis and zmr revision taper hip prosthesis including the indications for use contraindications and warnings. investigation has shown the potential for fracture of the zmr revision hip system where bone quality and bone quantity (especially in the proximal location) and resultant proximal support is not optimal. the device indication will now be limited to cementless revision hip arthroplasty.

Device

ZMR HIP SYSTEM - FEMORAL STEMS - POROUS STEMS
  • Model / Serial
    Model Catalog: 00-9981-225-22 (Lot serial: ALL LOTS); Model Catalog: 00-9981-210-32 (Lot serial: ALL LOTS); Model Catalog: 00-9981-210-22 (Lot serial: ALL LOTS); Model Catalog: 00-9983-240-33 (Lot serial: ALL LOTS); Model Catalog: 00-9983-240-32 (Lot serial: ALL LOTS); Model Catalog: 00-9983-225-34 (Lot serial: ALL LOTS); Model Catalog: 00-9983-225-33 (Lot serial: ALL LOTS); Model Catalog: 00-9983-225-32 (Lot serial: ALL LOTS); Model Catalog: 00-9983-210-34 (Lot serial: ALL LOTS); Model Catalog: 00-9983-210-33 (Lot serial: ALL LOTS); Model Catalog: 00-9983-210-32 (Lot serial: ALL LOTS); Model Catalog: 00-9983-195-34 (Lot serial: ALL LOTS); Model Catalog: 00-9983-195-33 (Lot serial: ALL LOTS); Model Catalog: 00-9983-195-32 (Lot serial: ALL LOTS); Model Catalog: 00-9983-180-34 (Lot serial: ALL LOTS); Model Catalog: 00-9983-180-33 (Lot serial: ALL LOTS); Model Catalog: 00-9983-180-32 (Lot serial: ALL LOTS); Model Catalog: 00-9983-165-34 (Lot serial: ALL LOTS); Model Catalog: 00-9983-165-33 (Lot serial: ALL LOTS
  • Product Description
    ZMR HIP SYSTEM POROUS STEMS LINE EXT.
  • 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