| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00907-1 |
| Product Name/Description |
Vanguard 360 Femoral Boss Reamer
Part number: 32-488474
Lot numbers: 095780, 308620, 418970, 708240, 726490, 953540
ARTG number: 116459 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
Biomet has initiated this action following an investigation which identified that the Vanguard 360 Femoral Boss Reamer may not fit into the mating component. This issue may result in delay to surgery while an unaffected reamer is sourced. It is likely that this issue will be identified prior to the surgical procedure. There have been no reports of patient injury related to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Hospitals are requested to immediately locate and discontinue use of the product and its return to Biomet. This action has been closed-out on 03/06/2016. |
| Contact Information |
02 9878 6100 - Biomet Australia QA/RA Specialist |