Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15262 |
| Brand Name: | Stryker OtisMed Shapematch Cutting Guides |
| Model: | Catalogue Numbers: TR3100-L, TR3100-R |
| Affected: | All lot numbers |
| Software version: | |
| Recalling Organisation: | Stryker New Zealand Ltd 515 Mount Wellington Highway Mount Wellington AUCKLAND 1060 |
| Contact Information: | 0800 787 9287 |
| Manufacturer: | Stryker Howmedica Osteonics |
| Issue: | The reason for this Hazard Alert is multifactorial: 1/ The surgical protocol for the ShapeMatch Cutting Guides did not provide sufficient information on: The position of the cutting guides, The need for osteophyte/soft tissue removal, The requirement for proper axial drilling and The need to avoid angulation and mal-alignment. 2/ The approved pre-operative plan did not provide sufficient information regarding the need for osteophyte removal. 3/ The values displayed via the OtisMed.net web portal were inconsistent with the pre-operative planning values used to manufacture some of the ShapeMatch Cutting Guides. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 2/9/2013 |
