Events

Recall of SPIRALOK Anchors (suture anchors used to reattach soft tissue to bone in orthopaedic surgery)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd T/A Depuy Australia.

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-2012-RN-00938-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00938-1
  • 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
    Testing has indicated that the spiralok anchors may not be as robust compared to other similarly indicated anchors and is removing it from the market.
  • Action
    Customers are requested to quarantine affected stock and contact the sponsor to organise return. Physicians are advised to report any patient events involving fractured anchors to the sponsor.

Device

SPIRALOK Anchors (suture anchors used to reattach soft tissue to bone in orthopaedic surgery)
  • Model / Serial
    SPIRALOK Anchors (suture anchors used to reattach soft tissue to bone in orthopaedic surgery)Product Codes: 222960, 222961, 222962, 222963, 222985, 222986, 222987 & 222988ARTG Numbers: 136226, 136227, 136226, 136227, 123272, 123017, 123272 & 123017
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia