Events

Recall of Persona (TASP) Tibial Articular Surface Provisional Shim

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-00013-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-01-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00013-1
  • 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 is initiating this recall due to provisional shims being found with missing ball bearings. zimmer’s investigation has found that repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim.This gives rise to the potential for delays in surgery and/or a missing part from the device being left in the wound.This issue was also identified following worn returns being reported through the worn instrument program.No complaints from australia have been received regarding this issue.
  • Action
    Customers are requested to inspect any product referenced within this notification before and after use for missing ball bearings and to provide any devices with missing ball bearings to your Zimmer sales representative for return. This action has been closed-out on 18/03/2016.

Device

Persona (TASP) Tibial Articular Surface Provisional Shim
  • Model / Serial
    Persona (TASP) Tibial Articular Surface Provisional Shim All sizes and lots Catalogue Number: 42-5279-003-00 thru 42-5279-009-04 ARTG number: 109936
  • 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