Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27215 |
| Brand Name: | On-X Prosthetic Aortic Heart Valves |
| Model: | CRY-ONXACE / CRY-ONXM / CRY-ONXMC |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | On-X Life Technologies Inc |
| Brand Name: | On-X Prosthetic Mitral Heart Valves |
| Model: | CRY-ONXACE / CRY-ONXM / CRY-ONXMC |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | On-X Life Technologies Inc |
| Issue: | The On-X Aortic extended valve holders and On-X Mitral standard valve holders were modified to eliminate the possibility of backward valve remounting by the clinician. The new design features separate non-interchangeable aortic and mitral specific holders such that noaortic valve could fit on a mitral holder and vice versa |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/1/2021 |
