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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00821-3
Product Name/Description Multiple Suture Anchors: Various models of HEALICOIL, TWINFIX, BIORAPTOR, FOOTPRINT Suture Anchors (Used to attach the end of a synthetic or natural ligament to bone)

Also Supplied separately and as part of the surgical arthroscopic procedure kit which is labelled with the suture model name.
Multiple catalogue numbers affected

All lot numbers affected

ARTG Numbers: 109451 and 120338
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 14/08/2012
Responsible Entity Smith & Nephew Surgical Pty Ltd
Reason/Issue The reason for this product recall is due to a packaging issue. Specifically, pin holes have been identified in a small number of pouches, which constitutes a breach of the sterile barrier.
Recall Action Recall
Recall Action Instructions Customers to remove affected units from use and contact the Sponsor to arrange for replacement stock.
Contact Information 02 9857 3917 - Smith & Nephew Regulatory Affairs