Events

Recall of Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants)

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-2015-RN-00554-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00554-1
  • 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
    There is a potential that the packaging integrity (sterile barrier) of the packaging type kit i may be compromised by transportation. a compromised sterile barrier could result in the surgeon selecting a back-up device or, if not recognised, an unintended implantation of a potentially non sterile device. the packaging type kit i consists of a white cardboard box, an outer peel pouch, and an inner peel pouch.
  • Action
    Stryker is notifying hospitals and surgeons of the issue and recovering stock supplied to hospitals. Surgeons are advised of the potential hazards involved in the implantation of devices where the sterile barrier has been breached. This action has been closed-out on 18/08/2016.

Device

Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants)
  • Model / Serial
    Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants)rHead Recon Stem Implant non-coated:Size 1 Item: RCNS160, Lot: 19804S2Size 2 Item: RCNS260, Lot: 19773-S2Size 3 Item: RCNS360, Lot: 19807S2Bipolar stem implant #1 Item RCNS1, Lot 19716S2Bipolar stem implant #3 Item RCNS3, Lot19720-S2Bipolar stem implant #4 Item RCNS4, Lot19816-S2Radial stem implant #1 Item RHAS1, Lot19778S2 Radial stem implant #4 Item RHAS4, Lot19814-S2
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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