| TGA Action ID |
RC-2026-RN-00400-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Hoffman 3 Universal Pin Chucks for Dia 4,5,6mm, stored within Hoffmann3 Instrument Sets
Universal Pin Chuck Catalogue Number: 49229050
Universal Pin Chuck Lot Numbers: 1544AB, AN4261, AP3761, AR4000, AU0794
GTIN: 07613327079098
Instrument Sets Catalogue Number: 49229900-T, 49339900-T |
| ARTG Number |
345574 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Certain lots of Hoffman 3 Universal Pin Chucks contain an inhomogeneous coating with out-of-specification coating thickness and colour.
The heterogeneity of the Ni PTFE coating may accelerate degradation and compromise device performance. In
addition, visible discoloration may lead users to perceive the device as unclean, contaminated, or containing debris, despite the discoloration being cosmetic only.
This nonconformance was discovered via product complaints. |
| Instructions for Customers/Users |
Customers are to:
- Inspect all Hoffman3 Instrument Sets on hand for affected lots of Universal Pin Chucks and quarantine any affected product.
A Stryker representative will help coordinate the return and replacement of any affected product. |
| Action Commencement Date |
26/05/2026 |
| Responsible Entity |
|
| Contact Information |
postmarketssp@stryker.com - Stryker |