Events

Recall of OSSEOTITE CERTAIN PREVAIL 2 IMPLANT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMET 3I 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
    153171
  • Event Risk Class
    III
  • Event Initiated Date
    2013-08-30
  • 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
    A visually observable condition which may be present on some of the implants have been identified. the condition is caused by the implant coming into contact with residual machining fluid which may have been left on the packaging insert. the condition does not meet the cleanliness criteria of biomet 3i.

Device

OSSEOTITE CERTAIN PREVAIL 2 IMPLANT
  • Model / Serial
    Model Catalog: XIIOS6510 (Lot serial: >10 numbers contact mfg); Model Catalog: XIIOS6511 (Lot serial: >10 numbers contact mfg); Model Catalog: XIIOS6513 (Lot serial: >10 numbers contact mfg); Model Catalog: XIFOSS610 (Lot serial: >10 numbers contact mfg); Model Catalog: XIFOSM313 (Lot serial: >10 numbers contact mfg); Model Catalog: XIFOSM311 (Lot serial: >10 numbers contact mfg); Model Catalog: XIFOSM310 (Lot serial: >10 numbers contact mfg); Model Catalog: IIOS5610 (Lot serial: >10 numbers contact mfg); Model Catalog: IOSM385 (Lot serial: >10 numbers contact mfg); Model Catalog: IOSM315 (Lot serial: >10 numbers contact mfg); Model Catalog: IOSM313 (Lot serial: >10 numbers contact mfg); Model Catalog: IOSM311 (Lot serial: >10 numbers contact mfg); Model Catalog: NINT685 (Lot serial: >10 numbers contact mfg); Model Catalog: NINT613 (Lot serial: >10 numbers contact mfg); Model Catalog: NINT611 (Lot serial: >10 numbers contact mfg); Model Catalog: NINT610 (Lot serial: >10 numbers contact mfg); Model Catalog: N
  • Product Description
    OSSEOTITE CERTAIN PREVAIL 2 IMPLANT
  • Manufacturer
    BIOMET 3I CANADA INC.

Manufacturer

BIOMET 3I CANADA INC.
  • Manufacturer Address
    ST. LAURENT
  • 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