Events

Recall of Zimmer Trabecular Metal Reverse Shoulder System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Zimmer 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
    15670
  • Event Initiated Date
    2013-11-20
  • 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
    Manufacturer launced the zimmer trabecular metal reverse shoulder system in 2006, with over 30,000 sold since launch. during the last 7 years, zimmer has received 90 complaints related to the glenosphere disassociating from the base plate or difficulty assembling the glenosphere to the base plate. this represents a complaint rate of approximately 0.27% since the product was introduced. based on the investigation of these complaints, zimmer determined that additional instructions specific to the assembly of the glenosphere to the base plate were necessary in order to emphasize important techniques. as a result, zimmer updated the applicable surgical technique and also released an instructional video specific to the assembly of the glenosphere. zimmer are providing instructional video specific to the assembly of the glenosphere.
  • Action
    Instructions for use to be updated

Device

Zimmer Trabecular Metal Reverse Shoulder System
  • Model / Serial
    Model: , Affected: 00-4349-036-11, 00-4349-038-11 and 00-4349-040-11
  • Manufacturer
    Zimmer Inc

Manufacturer

Zimmer Inc
  • 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