| TGA Action ID |
RC-2026-RN-00918-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
T2 ALPHA IMN Screws - Advanced Locking Screw D5x57.5mm
Catalogue Number: 23615057S
Lot Number: K17FE5A |
| ARTG Number |
340044 |
| Unique Device Identifier (UDI) |
(01)07613327381535(17)351031(10)K17FE5A |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Following a product complaint, Stryker has confirmed that one lot of T2 ALPHA IMN Advanced Locking is incorrectly labeled. The product contains a 75mm length screw instead of 57.5mm.
The potential harm associated with this problem is prolongation of surgery time to obtain a backup screw. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their inventory and quarantine any affected product they have.
- Contact Stryker to coordinate the return and replacement of any affected product. |
| Action Commencement Date |
11/11/2026 |
| Responsible Entity |
|
| Contact Information |
postmarketssp@stryker.com - Stryker Australia |