Events

Recall of CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone)

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-2016-RN-00484-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00484-1
  • 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 pivot cinchlock ss knotless anchor is a non-degradable implant device intended for the fixation of soft tissue to bone.Several complaints have been received relating to the pull wire breaking. there are two modes of failure identified for the pull wire; near the inserter handle and at the most distal tip where the wire ends with a larger diameter tip.The broken pull wire may spring out of the inserter handle that may injure the user. inserter components may break or disassemble leading to minor surgical delay to remove fragments or fragments left in bone after the procedure.
  • Action
    Stryker is advising users to inspect and quarantine any of the affected items. Affected stock can be returned to Stryker for replacement with unaffected stock. This action has been closed out 01 Feb 2017

Device

CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone)
  • Model / Serial
    CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone)Catalogue Number: CAT02462Lot Numbers: 15120801, 15121401, 16010402, 16011901, 16012501ARTG Number: 229717
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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