Events

Recall of AVS PL SPACER (Used as an aid in spinal fixation)

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-2014-RN-01131-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-10-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01131-1
  • 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
    The above catalogue numbers are specific to the us and supplied with the us labelling which has a different indication then those devices supplied outside of the us. specifically, the us versions indicated use with autogenous bone graft in patients with degenerative disc disease (ddd) at one level or two contiguous levels from l2 to s1. the australian indication does not include the limit to the contiguous levels or spinal region (l2-s1).
  • Action
    Stryker is requesting their customer to identify and return any affected stock. This action has been closed-out on 01/03/2016. This action has been closed-out on 01/03/2016.

Device

AVS PL SPACER (Used as an aid in spinal fixation)
  • Model / Serial
    AVS PL SPACER (Used as an aid in spinal fixation)AVS PL SPACER 7 X 20 X 4° 9MMCatalogue Number: 48340074Lot Numbers: 30646, 33494, 39184AVS PL SPACER 8 X 20 X 4° 9MMCatalogue Number: 48340084Lot Numbers: 33549, 38164, 38652, 39007, 39160AVS PL SPACER 7 X 25 X 4° 8MMCatalogue Number: 48345074Lot Number: 39188AVS PL SPACER 8 X 25 X 4° 8MMCatalogue Number: 48345084Lot Numbers: 39150, 38183ARTG Number: 178870
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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