| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01385-1 |
| Product Name/Description |
Wallis Posterior Dynamic Stabilisation System instruments and containers
Multiple Wallis Instruments and Reference Numbers affected
All Lots
ARTG Number: 157602 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
An updated cleaning and disinfection instruction for the Wallis Posterior Dynamic Stabilisation has been issued. Since the market launch of the Wallis Posterior Dynamic Stabilisation System in 2002, the instruments were distributed with Instruction for use related to the method for cleaning and disinfection at health care facilities; however, the method was not adequately validated. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer Biomet is advising users to follow the updated IFU (IFU Version 002WNAN0000T rev 2) for cleaning and decontamination.
This action has been closed out on 3/09/2018. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |