Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24170 |
| Brand Name: | Stryker Spine - I - 44759 - Fixation system implantation kit, internal |
| Model: | XIA 3 FRENCH BENDER, XIA 3 DEGENERATIVE INSTRUMENTS, XIA 3 COMPLEX ROD & MAC INST |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Stryker New Zealand Ltd 515 Mount Wellington Highway Mount Wellington AUCKLAND 1060 |
| Contact Information: | 0800 787 9287 |
| Manufacturer: | Stryker Spine |
| Issue: | The Xia 3 Degen Tray and the French Bender listed above did not successfully pass validation for a steam sterilisation cycle of 134°C for 3 minutes as the French Bender instrument contained within the tray did not meet the required sterility assurance level (SAL) of 10-6. Furthermore, since the Xia 3 Rod and Cross connector Tray has the same device design and configuration with respect to the French Bender instrument, it has been determined that it would also not successfully pass validation. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/2/2019 |
