Events

Recall of ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION LINER IMPACTOR 36MM 65 DEGREE NECK ANGLE

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
    31330
  • Event Risk Class
    II
  • Event Initiated Date
    2012-07-23
  • 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
    Lot specific recall due to reports of alignment peg fractures occurring in approximately 0.4% of surgeries. the recalled lots were manufactured from 455 stainless steel which is the material that all of the reported fractured instruments were manufactured from. due to the notch sensitivity of the 455 stainless steel the peg on the impactor manufactured with this material has a propensity for fracture. the remainder of lots that are not affected by this recall were made with 13-8 stainless steel.

Device

ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION LINER IMPACTOR 36MM 65 DEGREE NEC...
  • Model / Serial
    Model Catalog: 00-4309-029-01 (Lot serial: 60989817); Model Catalog: 00-4309-029-01 (Lot serial: 61024161); Model Catalog: 00-4309-029-01 (Lot serial: 61011689); Model Catalog: 00-4309-028-00 (Lot serial: 6109783); Model Catalog: 00-4309-028-01 (Lot serial: 61051017); Model Catalog: 00-4309-028-01 (Lot serial: 60936815); Model Catalog: 00-4309-029-00 (Lot serial: 61004027)
  • Product Description
    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION LINER IMPACTOR 36MM 65 DEGREE NECK ANGLE
  • 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