Events

Recall of rHead Radial Head and Uni-Elbow System

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-01347-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01347-1
  • 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 conducted a review of the currently available data of the stryker rhead radial head and uni-elbow system, and it was found to be inconclusive to continue supporting the performance of the device. the system is intended for replacement of the proximal end of the radius. this includes replacement of the radial head for degenerative or post-traumatic disabilities, presenting pain, crepitation and decreased motion at the radio humeral and/or proximal radio ulnar joint with joint destruction or subluxation visible on x-ray and resistance to conservative treatment.Post-operatively, the following may occur; implant loosening (septic and aseptic), instability (mod-severe), stress fracture (bone), cyst formation (bone resorption), stiffness, pain, impingement and heterotopic ossification.
  • Action
    Stryker is advising customers to inspect inventory for affected product and quarantine it immediately. Stryker will arrange collection of goods from affected sites. Health care professionals that have patients using the Stryker rHead Radial Head/Uni-Elbow Prosthesis System should continue to follow up those patients in accordance with the routine standard of care and be aware of this issue when doing so.

Device

rHead Radial Head and Uni-Elbow System
  • Model / Serial
    rHead Radial Head and Uni-Elbow SystemMultiple Item Numbers (see attached)All Lot NumbersARTG Numbers: 238712 (Stryker Australia Pty Ltd - Prosthesis, internal, joint, elbow, radial component)240014 (Stryker Australia Pty Ltd - Coated elbow humerus prosthesis)240015 (Stryker Australia Pty Ltd - Surgical procedure kit, orthopaedic, reusable)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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