Events

Recall of MCK Tibial Baseplate-RM/LL-SZ 2 and MCK Tibial Baseplate-RM/LL-SZ 7

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-01493-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01493-1
  • 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
    Stryker has discovered that the packaging of certain sizes and lots of the above-referenced product may contain the incorrect product and/or label. two reports were received with the product/label discrepancy. in one report, the labelling of the implant box outer label stated size 2 rm/ll, and the labelling of the implant sticker (patient label) located inside the outer box state size 7 rm/ll. the correct implant size 2 rm/ll was inside the box. the patient label was incorrect in this report. the second report described that a size 2 implant was in a box labelled as a size 7 implant.
  • Action
    Stryker is advising users to quarantine affected stock immediately. Customers should contact their Stryker representative to arrange for return of affected product.

Device

MCK Tibial Baseplate-RM/LL-SZ 2 and MCK Tibial Baseplate-RM/LL-SZ 7
  • Model / Serial
    MCK Tibial Baseplate-RM/LL-SZ 2 and MCK Tibial Baseplate-RM/LL-SZ 7Item No: 180612; Lot No: 26080317-01Item No: 180617; Lot No: 26150217-01ARTG Number: 242173
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA