| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00647-1 |
| Product Name/Description |
OSSEOTITE Certain PREVAIL 2 Implant 5/4 x 11.5mm
Item Number: XIIOS5411
Lot Number: 2011090247 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
A small percentage of the affected implant lot may contain a manufacturing condition where the implant's internal hex is not present.
This recall action was carried out prior to approval of the recall strategy by the TGA. |
| Recall Action |
Recall |
| Recall Action Instructions |
Biomet 3i are asking customers to return affected stock for replacement. |
| Contact Information |
1800 342 5454 - Biomet 3i |