| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00722-3 |
| Product Name/Description |
Low Profile Abutment Hexed Castable Cylinder, Model LPCCC1
Lot no's:2010100001, 2010080684, 2010090191 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Biomet 3i has become aware that some packages labelled LPCCC1, Hexed Castable Cylinder, may contain LPCCC2 Non-Hexed Castable Cylinder. According to Biomet 3i, this condition will not have any effect on patient health. However, difficulty may be encountered in the lab durung use due to the ease of rotation of the non hexed cylinder.
This recall action was not notified to the TGA before it was initiated by Biomet 3i Australia Pty Ltd. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is asking users to return affected stock for a replacement. |
| Contact Information |
02 9855 4444 - Biomet 3i |