| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00029-1 |
| Product Name/Description |
Various Sterile-Packaged Femoral Heads (Various sizes, neck lengths and taper sizes)
Multiple Item Numbers and Lot Numbers
Manufactured prior to June-2012 and distributed from May 2005 through November 2014
ARTG Numbers: 215999, 216181 & 99906 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer identified a subset of products that were manufactured prior to June -2012 and packaged in a specific configuration that failed packaging design verification test due to potential compromise of the inner sterile tray. This packaging configuration consists of a double sterile barrier. There are no known incidents where the outer tray was compromised. This recall is initiated to remove any unconsumed product given that the packaging may not have the double sterile barrier as intended. |
| Recall Action |
Recall |
| Recall Action Instructions |
Zimmer is requesting their customers to quarantine the affected product. Zimmer is arranging for the collection of the product through their sales representative. This action has been closed-out on 24/05/2016. |
| Contact Information |
02 9483 5400 - Zimmer |