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 |
|
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 |