| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01194-1 |
| Product Name/Description |
Ardis Inserter (intended for delivery of the Ardis interbody spacer into the prepared disc space)
Part Number: 3256-01
ARTG Number: 157926 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
The Ardis system implant may break when excessive lateral forces are applied to the implant during insertion. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Updated surgical technique guidance has been issued directly to surgeons to reduce the risk of off-axis loading when using the inserter. |
| Contact Information |
1800 803 263 - Zimmer Customer Service |