| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00070-1 |
| Product Name/Description |
DX FiberTak Suture Anchor, ST & NDLs
Part Number: AR-8990ST-1
Lot Number: 15147890
ARTG 353482
(Arthrex Australia Pty Ltd - Soft-tissue anchor, non-bioabsorbable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
29/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential for the content of the AR-8990ST-1 and AR-8990ST-2 inner pouches being mixed.
The user may notice but not before having unpackaged and likely implanted the device.
The Surgeon has the wrong device and must replace it or finish with what is available.
In the event the user wanted an AR-8990ST-1 but received an AR-8990ST-2, the user is likely going to cut the extra suture with no harm to the patient. The difference in suture size is not expected to impact the outcome of the surgery.
Affected batches for AR-8990ST-2 have not been supplied in Australia. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users should quarantine and segregate any affected stock from the affected Material and Batch.
Users with affected stock should contact their Arthrex Representative and respond with the Acknowledgement Form to Arthrex ANZ Quality so a return can be arranged. |
| Contact Information |
0403 258 345 - Shane Hawes |