Events

Recall of GemLock Long Hex Driver

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Zimmer Pty Ltd.

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
    RC-2015-RN-00146-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00146-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Zimmer dental identified that certain lots of the gemlock long hex driver, catalogue rhl2.5, may not fit into the fixture mount transfer (fmt) or the internal hex of the implant. the affected product was also distributed within the tapered swissplus & swissplus implant systems kit, surgical, complete, catalogue opcst as well as the tapered screw-vent implant system surgical kit, complete, catalogue tsvkit.
  • Action
    Zimmer is requesting their customers to quarantine the affected units. A Zimmer distributor will arrange for the removal of affected products. This action has been closed-out on 4/08/2016.

Device

GemLock Long Hex Driver
  • Model / Serial
    GemLock Long Hex Driver Catalogue Number: TSVKITLot Number on Label: 62702589*Etched Lot Number of RHL2.5: 62699693* Not all drivers used to assemble this kit lot are affected, as multiple lots of the driver were used to manufacture the kits. Drivers etched with lot 62632712, which function appropriately. Lot Number on Label: 62743075Etched Lot Number of RHL2.5: 62735177ARTG number: 126570
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • 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
    DHTGA