| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01266-1 |
| Product Name/Description |
STAR Instruments Kit, sterile packaged (used to implant Scandinavian Total Ankle Replacement System)
Multiple instruments within the STAR Instruments Kit
Item Number: 100-0071
Lot Numbers: 20320, 30332
ARTG Number: 240015 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has become aware during an internal review that some items of the STAR Sterile Instrument Kit have been unintentionally shipped to Australia without being CE marked. Non-sterile instrument alternatives are available for the Australian market. Based on design review by Stryker and the availability of the necessary IFU information, no hazards are to be expected. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to inspect the inventory and quarantine any affected stock immediately. A Stryker representative will coordinate the return of any affected product. This action has been closed-out on 11/05/2017. |
| Contact Information |
02 9467 1175 - Stryker |