| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01132-1 |
| Product Name/Description |
50mm Left Standard Ti Mandible
(Titanium Mandible Implants)
Item Reference : 24-6551TI
Batch numbers: 525190A & 525190B
ARTG Number: 145265 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Biomet Microfixation has initiated this action following an internal investigation which identified that the Titanium Mandible Implants may exhibit fatigue fracture due to a laser etch that was delivered at a more powerful setting resulting in a wider and deeper etch. The laser is used to etch the part number, lot number, and logo on the implant. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Biomet Australia is notifying surgeons and hospitals of the potential problem and providing instructions for clinical follow up. Further information can be found on the TGA website. This action has been closed-out on 06/06/2016. |
| Contact Information |
02 9878 6100 - Biomet Regulatory Affairs |