| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00813-3 |
| Product Name/Description |
E1-Tapered 10 degree +3mm Liner 32/39 (hip joint prosthesis, acetabular component)
Product Part Number: E1-103239
Lot Number: 2011010452
ARTG Number: 120149 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Biomet Spain Orthopaedics S.L. has initiated this action following the investigation on a reported event. It has been confirmed that in a few cases the affected product does not properly fit in the acetabular cup. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Biomet Australia is contacting the treating/implanting surgeon regarding the issue so that the affected patient can be appropriately managed. |
| Contact Information |
02 9878 6100 - Biomet Australia Regulatory Affairs |