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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