| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01273-1 |
| Product Name/Description |
Various Optetrak Devices - Spine Stiffener Screw and Constrained Condylar (CC) Tibial Insert when used in conjunction with Offset Tibial Tray
Multiple Catalogue Numbers and Products
All serial numbers affected
ARTG Number: 252474 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Exactech initiated a corrective action for the affected catalogue numbers due to a design incompatibility between the Optetrak Offset Spine Stiffener Screw and the Optetrak Constrained Condylar (CC) Tibial Insert when used in conjunction with an Optetrak Offset Tibial Tray.
The Optetrak Offset Spine Stiffener Screw is offered in a variety of sizes and is used as a secondary means to secure the Optetrak Constrained Condylar (CC) Tibial Insert to the Optetrak Offset Tibial Tray. In all but one combination, the next size Optetrak Offset Spine Stiffener Screw can be used without any anticipated adverse health consequences. Exactech anticipates there may be a slight surgical delay while a larger screw is opened.
This action was undertaken prior to consultation with the Therapeutic Goods Administration (TGA). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Exactech has provided users with an updated compatibility chart.
This action has been closed out on 10/01/2019 |
| Contact Information |
02 8882 9688 - Exactech Australia |