| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00733-1 |
| Product Name/Description |
AVS ARIA Implant Inserter
Item number: 48758500 (Located in Instrument Tray 48759040-T)
Lots numbers affected: 107400, 10G906, 110214
ARTG number: 178870 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has received reports of fracture of the vertebral PEEK spacers when implanted with the AVS ARIA Implant Inserter. According to the reported complaints, the proximal end of the implant either cracks or the tip breaks off in one fragment. There have been no reports of the broken fragment remaining in the surgical site. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising their customers to quarantine any affected lots and will arrange for the return of any affected lots from the field. |
| Contact Information |
1800 803 601 - Stryker Australia |