Events

Recall of NEXGEN COMPLETE KNEE SOLUTION - CR PRECOAT FEMORAL COMPONENT MICRO

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
    59023
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-12
  • 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
    Since the march 2012 notification zimmer has monitored the occurrence of non-compatible micro component combinations being implanted. this included the usage of micro femurs and micro patellae in addition to micro articular surfaces. although the occurrence has been reduced since the 2012 notification it has not been eliminated and therefore zimmer is initiating a recall to remove the affected devices [implants and provisionals (a reusable joint specific trial device used in orthopedic joint replacement to validate the proper size of the permanent prosthesis)] and prevent this issue from recurring.

Device

NEXGEN COMPLETE KNEE SOLUTION - CR PRECOAT FEMORAL COMPONENT MICRO
  • Model / Serial
    Model Catalog: 00597001202 (Lot serial: ALL LOTS); Model Catalog: 00597001101 (Lot serial: ALL LOTS); Model Catalog: 00597001201 (Lot serial: ALL LOTS); Model Catalog: 00597001102 (Lot serial: ALL LOTS); Model Catalog: 00-5956-012-02 (Lot serial: ALL LOTS); Model Catalog: 00-5956-012-01 (Lot serial: ALL LOTS); Model Catalog: 90-5970-020-09 (Lot serial: ALL LOTS); Model Catalog: 00597203117 (Lot serial: ALL LOTS); Model Catalog: 00597203114 (Lot serial: ALL LOTS); Model Catalog: 00597203112 (Lot serial: ALL LOTS); Model Catalog: 00597203110 (Lot serial: ALL LOTS); Model Catalog: 00597203109 (Lot serial: ALL LOTS); Model Catalog: 00597202020 (Lot serial: ALL LOTS); Model Catalog: 00597202017 (Lot serial: ALL LOTS); Model Catalog: 00597206135 (Lot serial: ALL LOTS); Model Catalog: 00597206132 (Lot serial: ALL LOTS); Model Catalog: 00597206129 (Lot serial: ALL LOTS); Model Catalog: 00597206126 (Lot serial: ALL LOTS); Model Catalog: 00-5952-012-02 (Lot serial: ALL LOTS); Model Catalog: 00-5952-012-01 (Lot serial:
  • Product Description
    NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) PRECOAT FEMORAL COMPONENT
  • 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