Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24800 |
| Brand Name: | Mako RIO |
| Model: | |
| Affected: | Affected Stock - GUD536, GUD711 |
| Software version: | |
| Recalling Organisation: | Stryker New Zealand Ltd 515 Mount Wellington Highway Mount Wellington AUCKLAND 1060 |
| Contact Information: | 0800 787 9287 |
| Manufacturer: | Mako Surgical Corp |
| Issue: | The manufacturer has discovered that the audio volume of the Mako System is unable to be adjusted in certain guidance modules. The volume of the Mako System originates from the audio chip within the SS2U Computer. The SS2U Computer is a subcomponent of the Guidance Module. It was noted that the audio chip preassembled within the SS2U Computer had changed from the specified audio chip to a different audio chip. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 4/7/2019 |
