Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19172 |
| Brand Name: | Synthes Sternal ZIPFIX Application Instrument |
| Model: | 03.501.080 |
| Affected: | Multiple lot numbers |
| Software version: | |
| Recalling Organisation: | Johnson & Johnson (NZ) Limited 13a Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 922 638 |
| Manufacturer: | Synthes GmbH |
| Issue: | In the affected lots of the Application Instrument for Sternal ZIPFIX : * The end cap may loosen, thus reducing the tension applied to the implant. * The end cap may detach, allowing the tensioning spring to also become detached, making the instrument non-functional. If the end cap is loose, the maximum tension applied to the implant is reduced and may lead to insufficient sternal bone reduction. If the tension coil spring detaches completely from the ZIPFIX Application instrument while closing the sternum, it is possible that the spring or nut could fall into the thoracic cavity and go undetected. If the nut/spring is retained in the thoracic cavity, adverse tissue reaction may occur. No such occurrence has been reported to date. |
| Recall action type: | Correction |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Sponsor Control |
| Date Commenced: | 23/9/2015 |
