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 |
|
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 |