| TGA Action ID |
RC-2025-RN-00403-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Stryker Micro-Oscillating and Sagittal Blades
Product Descriptions: PREC THIN 9.0 X 0.38 X 18.5MM, PREC THIN 13.0 X 0.38 X 39.0MM
Lot Numbers: 23070017, 22298017
Catalogue Numbers: 2296-003-155, 2296-003-108
GTIN: 04546540466549, 04546540046482 |
| ARTG Number |
140542 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Precision Thin blade attachments have the potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
An incomplete fit into the handpiece may result in a decrease in device performance and may also cause the blade to disengage from the handpiece. |
| Instructions for Customers/Users |
Customers should Immediately inspect inventory for affected product and dispose of these.
Customers should contact their local Stryker representative to coordinate the replacement of any affected product they have
This action has been finalised on 7/7/2025. |
| Action Commencement Date |
17/04/2025 |
| Responsible Entity |
|
| Contact Information |
postmarketssp@stryker.com - Stryker Australia |