| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00484-1 |
| Product Name/Description |
CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone)
Catalogue Number: CAT02462
Lot Numbers: 15120801, 15121401, 16010402, 16011901, 16012501
ARTG Number: 229717 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
The Pivot CinchLock SS Knotless Anchor is a non-degradable implant device intended for the fixation of soft tissue to bone.
Several complaints have been received relating to the pull wire breaking. There are two modes of failure identified for the pull wire; near the inserter handle and at the most distal tip where the wire ends with a larger diameter tip.
The broken pull wire may spring out of the inserter handle that may injure the user. Inserter components may break or disassemble leading to minor surgical delay to remove fragments or fragments left in bone after the procedure. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising users to inspect and quarantine any of the affected items. Affected stock can be returned to Stryker for replacement with unaffected stock. This action has been closed out 01 Feb 2017 |
| Contact Information |
02 9467 1070 - Stryker - Product Queries
02 9467 1175 - Stryker - Recall of Product Queries |