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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