| 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 |
|
| 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 |