Database updated: 11 September 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36997 |
| Brand Name: | MAKO Robotic surgical navigation system application software |
| Model: | TKA 2.1, THA 4.2, PKA 3.1 Install Disk - THA 5.0, TKA 2.1, PKA 3.1 Install Disk - TKA 3.0, THA 5.0, PKA 3.1 Install Disk - TKA 3.0, THA 4.2, PKA 3.1 Install Disk |
| Affected: | Catalogue Numbers - 700002834690, 700003123526 |
| 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 become aware that there is the potential for the user to experience a discrepancy in the on-screen visualisation of bone resection and the actual amount of bone removed during the reaming process when using Total Hip Arthroplasty (THA) 4.2 and THA 5.0 applications on the Mako 4 Robotic Arm (P/N 229999). The user may observe excessive red and/or a black area in the acetabulum displayed on the screen when there is pelvic motion in a certain direction relative to the reamer. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/7/2026 |
