| TGA Action ID |
RC-2026-RN-00540-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
T2 Alpha Tibia Nailing System
Product Description: IMN Instruments Locking Drill D4.2x360mm
Catalogue Number: 23514236S
Lot Numbers: K1534DF, K1534E0, K1534E5 |
| ARTG Number |
288589 |
| Unique Device Identifier (UDI) |
07613327350241 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Stryker confirmed that specific lots of IMN Instruments Locking Drills were manufactured with an oversized flat at the coupling piece of the drill bit. This problem prevents the insertion of the drill into the coupling attachment.
The problem was discovered via product complaints. |
| Instructions for Customers/Users |
Customers are to:
1. Immediately inspect their inventory for affected items and quarantine any affected product they have.
2. Contact your local Stryker representative to coordinate the return and replacement of any affected items identified. |
| Action Commencement Date |
17/07/2026 |
| Responsible Entity |
|
| Contact Information |
postmarketssp@stryker.com - Stryker Australia |