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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