Events

Recall of SwiveLock SP Suture Anchor

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-00463-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00463-1
  • 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
    It has been determined that there is an issue with specific batches of the self-punching eyelet contained within the arthrex swivelock sp suture anchor which may cause the eyelet to break on insertion in hard bone.Please note that there is no impact to the patient if the device has been implanted successfully.
  • Action
    Device Technologies Australia (DTA) is requesting users to immediately discontinue use of the affected devices and to inform all relevant personnel at their facility of the recall notice. Users are further requested to quarantine their affected stock and return a completed Reply Fax Form, advising the quantity of affected stock. Users are advised that credit will be issued upon DTA's receipt of the returned items.

Device

SwiveLock SP Suture Anchor
  • Model / Serial
    SwiveLock SP Suture AnchorProduct Codes: AR-2323BSLM, AR-2323PSLM, AR-2324BCM, AR-2324PSLM, AR-2600SBS-5, AR-2600SBS-7Multiple Products and Batch NumbersARTG Numbers: 126657 and 164046
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd