Events

Recall of BIOLOX OPTION CERAMIC FEMORAL HEAD TAPER 12/14

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
    44728
  • Event Risk Class
    II
  • Event Initiated Date
    2011-09-16
  • 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
    Zimmer gmbh is initiating a recall by issuing a revised instructions for use (ifu) for the biolox option ceramic femoral head system sizes 28mm to 40mm. zimmer determined that the current information as described in the ifu and in the design rational document was confusing. the system offers the option to treat primary and revision cases. in hip revision surgery the original stem could remain in situ. for this specific scenario the biolox option ifu and the design rationale document related to the heads have been revised to improve the definition for the level of allowed damage for the stem taper.

Device

BIOLOX OPTION CERAMIC FEMORAL HEAD TAPER 12/14
  • Model / Serial
    Model Catalog: 00877703604 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877704004 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877704003 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877704002 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877704001 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877702801 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877703603 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877703602 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877703601 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877703204 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877703203 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877703202 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877703201 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877702804 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877702803 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 008
  • Product Description
    BIOLOX OPTION CERAMIC FEMORAL HEADS
  • 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