Events

Recall of VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432

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-01262-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01262-1
  • 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
    During a product presentation it has been recognised that a screw is not held by the screwdriver blade. the missing retaining function is caused by the inner torx of the screws partly being out of specification. investigations have revealed that screws might exceed given tolerances. a missing retaining function can lead to the surgeon having difficulties to pick the screw out of the screw rack without any further means, such as tissue forceps or other forceps, or during transfer of the screws. difficulties during pick up or transfer of the screws could potentially cause additional time under anaesthesia due to prolongation of surgery.
  • Action
    Stryker is advising users that the affected screws can be continued to be used and will be replaced once unaffected stock is available. This action ha been closed-out on 29/08/2016.

Device

VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432
  • Model / Serial
    VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432Multiple Lot Numbers affectedIncluded in VariAx Compression EPS system trayCatalogue Number: 940081-TAll lot numbers affectedARTG Number: 239272
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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