Events

Recall of MOORE HIP PROSTHESIS SOLID LONG STRAIGHT STEM

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
    70841
  • Event Risk Class
    II
  • Event Initiated Date
    2013-07-19
  • 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
    During internal testing zimmer found that a single packaging tray configuration which consists of an inner and an outer sterile tray did not pass the established requirements for seal integrity and seal strength. approximately 2% of either the inner or outer tray did not pass these requirements. this tray configuration is used for the moore hip prosthesis long fenestrated stem.

Device

MOORE HIP PROSTHESIS SOLID LONG STRAIGHT STEM
  • Model / Serial
    Model Catalog: 00402100843 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00402101257 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00402101251 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00402101249 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00402101248 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00402101246 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00402101244 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00402101243 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00402101241 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00402101238 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00402100851 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00402100849 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00402100848 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00402100846 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 00402100844 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    MOORE HIP LONG FENESTRATED STEM
  • 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