Events

Recall of PROVIDE PROTECTION CAP

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
    130066
  • Event Risk Class
    II
  • Event Initiated Date
    2015-09-21
  • 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
    Through investigatin biomet 3i determined that the provided protection caps (ppc***) and the provide impression copings (pic***) have not demonstrated adequate biocompatibility . in that the items were both found to elicit a cytotoxic response (grade 4).

Device

PROVIDE PROTECTION CAP
  • Model / Serial
    Model Catalog: PPC484 (Lot serial: More than 10 contact manuf.); Model Catalog: PPC654 (Lot serial: More than 10 contact manuf.); Model Catalog: PPC655 (Lot serial: More than 10 contact manuf.); Model Catalog: PPC485 (Lot serial: More than 10 contact manuf.)
  • Product Description
    PROVIDE PROTECTION CAP
  • 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