| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00571-1 |
| Product Name/Description |
FiberTak Double Loaded w/1.3 SutureTape
Part number: AR-3602-2-1
Lot number: 15243186
ARTG 353482
(Arthrex Australia Pty Ltd - Soft-tissue anchor, non-bioabsorbable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential for AR-3602-2-1 Double-Loaded devices to not fit with available Arthrex drill guides. This may result in procedural delay, while an alternate device is sought. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to quarantine and segregate any affected stock and notify their representative to arrange for a return and a credit to be applied. |
| Contact Information |
1800 950 637 - Arthrex Customer Service |