Events

Recall of RHD2.5 Hex Driver, 2.5mm with GemLock Retention, contained within TSVKIT Surgical Kit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Biomet 3i Australia 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-2017-RN-01320-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01320-1
  • 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 biomet has identified that the 2.5mm gemlock hex driver, rhd2.5 contained within a surgical kit may contain a manufacturing anomaly affecting the geometry of the driver’s hex feature, which prevents it from properly engaging with mating components. the rhd2.5 hex driver is used to carry and drive the implant into the osteotomy by connecting to the fixture mount/transfer or directly to the implant. two instruments, rh2.5 and rh2.5l, may be utilised as alternatives to the rhd2.5.
  • Action
    Zimmer Biomet is advising customers to review their inventory and return affected drivers. Please note that this recall is specific to the hex driver and as such there is no need to return entire surgical kit. Zimmer Biomet will provide replacement RHD2.5 hex drivers to affected customers upon return of affected RHD2.5 hex drivers. Two instruments, RH2.5 and RHL2.5 may be utilised as alternatives to the RHD2.5.

Device

RHD2.5 Hex Driver, 2.5mm with GemLock Retention, contained within TSVKIT Surgical Kit
  • Model / Serial
    RHD2.5 Hex Driver, 2.5mm with GemLock Retention, contained within TSVKIT Surgical KitSurgical KitItem Number: TSVKITLot Number: 63666560UDI Number: (01)00889024019614(10)63666560ARTG Number: 126570 (Biomet 3i Australia Pty Ltd - Dental implant suprastructure device, temporary)
  • Manufacturer
    Biomet 3i Australia Pty Ltd

Manufacturer

Biomet 3i Australia 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