Events

Recall of 6.5 Cancellous Bone Screw 35mm (Used in total hip joint arthroplasty when the surgeon elects to use a cluster/multi-hole shell in the acetabulum prosthetic component)

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-2012-RN-00882-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00882-1
  • 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 orthopaedics has received reports from the field indicating that certain lots of 6.5mm cancellous bone screws are potentially associated with a product label mix. the packaging label associated with a 35mm screw may contain a 25mm screw.
  • Action
    Recall and replacement of affected lots

Device

6.5 Cancellous Bone Screw 35mm (Used in total hip joint arthroplasty when the surgeon elects to u...
  • Model / Serial
    6.5 Cancellous Bone Screw 35mm (Used in total hip joint arthroplasty when the surgeon elects to use a cluster/multi-hole shell in the acetabulum prosthetic component)Catalogue Number: 2030-6535-1Lot Numbers: MLH17R, MLJDJT and MLH3K8
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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