| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01114-1 |
| Product Name/Description |
Stryker Instruments Heavy Duty Sagittal Blade 18x0.97x90mm (used to cut bone and bone related tissue in orthopaedic procedures)
Item Number: 6118-097-090
Lot Number: 16029017
ARTG Number: 140542 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
For a small portion of the affected lot, the seal between the top and base rollstock material of the product packaging may not have been manufactured correctly resulting in a sterile barrier breach. Due to this breach in sterility, there is a potential for a bone or soft tissue infection which may require medical or surgical intervention. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising users to inspect inventory for the affected lots and quarantine immediately. Affected stock can be returned to Stryker for replacement with unaffected product. This action has been closed-out on 10/05/2017. |
| Contact Information |
02 9467 1175 - Stryker (Recalls Specialist) |