| TGA Action ID |
RC-2025-RN-00910-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
SUTURE ANCHOR, BIOCOMPOSITE CORKSCREW
Part Number: AR-1927BCF-3-1
Lot Number: 15477011 |
| ARTG Number |
354971 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Arthrex has identified the potential for a specific batch of Suture Anchor Biocomposite Corkscrew to have 17-7 SS metal shavings in the ID of the device.
The introduction of metal shavings may lead the user to attempt removing them, or to be left in the patient if they cannot be removed or found or are not noticed. This could lead to localised patient reaction, persistent discomfort due to potential for nickel release.
While the user may be able to notice metal shavings during use, it is also possible it will not show on camera, not be noticed or not retrieved intentionally. |
| Instructions for Customers/Users |
Customers are to:
- Inspect inventory and quarantine any affected stock.
- Contact Arthrex to arrange return of affected stock.
- Arthrex will provide a credit for affected stock, and unaffected batches are readily available to order.
This action has been closed out on 20/11/2025. |
| Action Commencement Date |
21/10/2025 |
| Responsible Entity |
|
| Contact Information |
1800 950 637 - Arthrex Customer Service |