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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00678-3
Product Name/Description Twinfix Ultra Ti Suture Anchor, 5.5mm (used to attach the end or ends of a synthetic or natural ligament to bone)

Catalogue Numbers: 72202618 & 72202895

Multiple lot numbers

ARTG Number: 109451
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 5/07/2012
Responsible Entity Smith & Nephew Surgical Pty Ltd
Reason/Issue The manufacturer has advised that the distal part of the anchor may break on insertion into bone during surgery. The surgery may be completed using an alternative fixation device and, in most cases, the broken anchor can be retrieved with a grasper or sharp instrument.
Recall Action Recall
Recall Action Instructions Quarantine and return affected stock to Smith & Nephew Surgical for replacement.
Contact Information 02 9857 3987 - Smith & Nephew Regulatory Affairs