| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00207-1 |
| Product Name/Description |
TRIATHLON Baseplate Impactor/Extractor (Included in the reusable Triathlon primary or revision knee implantation kits)
Catalogue Number: 65414805
Multiple lot numbers affected
ARTG Number: 140892 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
6/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly instrument. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is asking customers to inspect Triathlon consignment instrument kits for affected lot numbers and remove any affected items from the Triathlon instrument kit. |
| Contact Information |
1800 803 601 - Stryker Regulatory Affairs |