| TGA Action ID |
RC-2025-RN-00743-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
System 7/8/9 Reciprocating Saw & System 8 Sternum Saw
Catalogue Numbers: 7206000000, 8206000000, 9206000000, 8207000000
GTIN Numbers: 07613327064834, 07613327304473, 07613327142716, 07613327304398
Multiple lot numbers |
| ARTG Number |
285715 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is a potential for the Compression Spring (0038-419-000) inside the saw’s drivetrain assembly to disengage during blade loading and unloading. A disengaged spring disables the blade collar from springing back to its original home position, potentially leading to blade retention failure when loading a blade. |
| Instructions for Customers/Users |
Customers are to: 1. Immediately inspect inventory to locate and quarantine any affected products they have. 2. Be aware that Stryker’s ProCare team will contact affected customers to arrange for affected devices to be repaired. The devices will be returned to customers upon completion of the repair.
This action has been closed out on 04/03/2026. |
| Action Commencement Date |
26/08/2025 |
| Responsible Entity |
|
| Contact Information |
postmarketssp@stryker.com or 0437 112 648 - Avalon Grygorcewicz |