Print version of this report
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 Zimmer Pty Ltd
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