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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00844-1
Product Name/Description	Bio-Absorbable Suture Anchors (Soft tissue fixation device) Part Numbers: 7220257, 72202602, 72202603, 72202624, 72202626, 72200775, 72201991, 72202165, 72201992, 72201996, 72201993, 72201994 and 72201995 ARTG Numbers: 181234, 181413, 161696, 164725, 164726 and 164727
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	8/08/2013
Responsible Entity	Smith & Nephew Surgical Pty Ltd
Reason/Issue	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.
Recall Action	Recall
Recall Action Instructions	Smith & Nephew is requesting users to inspect stock and remove any affected sutures for replacement.
Contact Information	02 9857 3917 - Smith and Nephew Regulatory Affairs