Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15331 |
| Brand Name: | Synthes Sternal ZipFix System |
| Model: | Part Number: 03.501.080 |
| Affected: | Lot numbers prior to 8100630 |
| Software version: | |
| Recalling Organisation: | Synthes New Zealand Ltd 507 Mt Wellington Highway Mt Wellington Auckland 1060 |
| Contact Information: | 0800 657 734 |
| Manufacturer: | Synthes GmbH |
| Issue: | The Technique Guide includes a precaution that the trigger must be released before and during cutting and that no cutting should take place under tension, however when using the 1st generation Application Instrument for Sternal ZipFix™ it is possible to cut the implant while the tensioning trigger is being squeezed (known as being cut under tension). NOTE: This issue applies to Application Instrument lots prior to 8100630 only (referred to as '1st generation' instruments). |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 4/9/2013 |
