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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01000-1
Product Name/Description Zimmer Natural Nail CM Long- Cephalomedullary Nails

All product manufactured and packaged between July 2009 to July 2015

Multiple product codes and lot numbers affected

ARTG Number: 169894
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/10/2015
Responsible Entity Zimmer Pty Ltd
Reason/Issue The Cephalomedullary Nails are packaged in double sterile barrier packaging that includes the placement of the product in a protective pouch and then into two sterile barrier trays (inner and outer). In approximately 5% of the tested samples, the outer tray was found to be compromised, however, there were no records which suggested that the sterility of the inner tray was affected. To date no complaints have been received regarding compromised packaging.
Recall Action Recall for Product Correction
Recall Action Instructions Zimmer is advising users to inspect current stock for damaged packaging and quarantine any affected units. Damaged product can be returned to Zimmer for replacement. This action has been closed-out on 22/08/2016.
Contact Information 02 9950 5426 - Zimmer