Events

Recall of Zimmer Femoral Heads and Taper

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Zimmer GmbH.

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
    17989
  • Event Initiated Date
    2015-01-22
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Zimmer Biomet New Zealand Company, 210 Khyber Pass Road, Grafton, Auckland
  • Reason
    Zimmer identified a subset of products that were manufactured prior to mid-2012 and packaged in a specific configuration that failed a packaging test due to potential compromise of the inner sterile tray. this packaging configuration consists of a double sterile barrier. there are no known incidents where the outer tray was compromised; therefore the device remains sterile when delivered during surgery. this recall is not related to sterility concerns, but rather the removal of any unconsumed product given that the packaging may not have the double sterile barrier as intended.
  • Action
    Product to be returned to supplier

Device

Zimmer Femoral Heads and Taper
  • Model / Serial
    Model: 32 models, Affected: Product distributed between May-2005 through Nov-2014
  • Manufacturer
    Zimmer GmbH

Manufacturer

Zimmer GmbH
  • 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
    NZMMDSA