| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00908-1 |
| Product Name/Description |
Patient Labels for Zimmer orthopaedic implants manufactured prior to March 2010. |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
In rare cases, product information on the patient label, with respect to REF number/LOT number, might not coincide with the corresponding information on the product label. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer have provided work around instructions for users to implement. |
| Contact Information |
02 9950 5470 - Zimmer Regulatory Affairs |