| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01183-1 |
| Product Name/Description |
Biomet 2.5MM offset tibial tray adaptor (tibial component of knee joint prosthesis)
Lot numbers: 439700 and 533400
ARTG Number: 98451 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
Specific batches were found to have an oversized adaptor locking insert that may not engage correctly with the insert tool screwdriver. This has the
potential to delay surgery. There are no problems expected post implantation. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Biomet is advising that once implanted, no additional risk to patient safety exists and no further action is required. |
| Contact Information |
02 9878 6100 - Biomet Australia Regulatory Affairs |