| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00659-1 |
| Product Name/Description |
Specialty Size 33mm Reduced Diameter Reaming Cutter
Catalogue Number: I-K0913DC33
All lots affected
ARTG Number: 140892 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has discovered that the Specialty 33mm Cutter outer diameter was designed too large and would thus prevent the device from passing through the Specialty Clamping Barrel.
This may result in the surgery time being extended by up to 15 minutes to retrieve and use an alternative readily available instrument. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising customers to inspect stocks and quarantine any affected units prior to their return to Stryker. This action has been closed-out on 03/02/2017. |
| Contact Information |
02 9467 1175 - Stryker |