| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00282-2 |
| Product Name/Description |
Virage Occipital-Cervical-Thoracic (OCT) Spinal Fixation System - Closure Caps (used to stabilise support or correct alignment of spinal vertebrae)
Item Number: 07.01728.001
All Lots affected
ARTG Number: 111775 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Spine has received complaints of Closure Top loosening. Loosening may occur when there is off-axis driver pressure and when the rod is not fully seated prior to application and final tightening of Closure Top.
The most probable risks associated with off-axis tightening of the Closure Top and final tightening of the Closure Tops prior to the rod being fully seated in the screw is loosening of the Closure Tops which may result in a revision surgery. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer Spine is providing users with additional technique guidance in advance of an updated Surgical Technical Manual for the Virage OCT Spinal Fixation System. Surgeons are advised to adhere to the additional guidance provided with the customer letter to minimise the risk of improper locking of the construct. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |