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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00924-1
Product Name/Description	Application Instrument for Sternal ZipFix Part Number: 03.501.080 Lot Number: All 1st generation Application Instruments - Lots prior to 8100630 ARTG Number: 153950
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	3/09/2013
Responsible Entity	Synthes Australia Pty Ltd
Reason/Issue	There is potential for ZipFix implants to loosen if the implant is cut while the tensioning trigger is being squeezed. Implants cut under tension can cause deformations in the teeth of the locking mechanism thereby compromising the integrity of the implants. The possibility exists for the ZipFix implant to be compromised and loosen after implantation or during the post operative recovery period.
Recall Action	Recall
Recall Action Instructions	Customers are requested to contact their local Sales Consultant to arrange for replacement with a 2nd generation Application Instrument. DePuy Synthes has confirmed that all 1st generation applicators in loan sets will be replaced with 2nd generation applicators.
Contact Information	1800 796 843 - Synthes Australia Customer Service