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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