Events

Recall of Bio-Absorbable Suture Anchors (Soft tissue fixation device)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew Surgical 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-2013-RN-00844-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00844-1
  • 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
    Smith & nephew advises that bio-absorbable suture anchors with the affected catalogue numbers are being recalled due to a packaging issue. specifically, pin holes and/or tiny slits (0.5mm - 5.0mm) have been identified in a small number of the primary pouches that may constitute a breach of the sterile barrier.
  • Action
    Smith & Nephew is requesting users to inspect stock and remove any affected sutures for replacement.

Device

Bio-Absorbable Suture Anchors (Soft tissue fixation device)
  • Model / Serial
    Bio-Absorbable Suture Anchors (Soft tissue fixation device)Part Numbers: 7220257, 72202602, 72202603, 72202624, 72202626, 72200775, 72201991, 72202165, 72201992, 72201996, 72201993, 72201994 and 72201995ARTG Numbers: 181234, 181413, 161696, 164725, 164726 and 164727
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd