Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16293 |
| Brand Name: | Hintegra Total Ankle Prosthesis |
| Model: | 49 models |
| Affected: | All unexpired lots |
| Software version: | |
| Recalling Organisation: | Integra Neurosciences Pty Ltd (NZ) 12 Florence Avenue Orewa Auckland 0931 |
| Contact Information: | 0800 400 660 |
| Manufacturer: | Newdeal SAS |
| Issue: | The manufacturer is notifying users that there is a risk of damage to the package (external pouch) of the Hintegra total ankle prosthesis tibial and talar components during shipping/handling. This damage might lead to a breakage of the sterility barrier of this external pouch, thus posing the risk of a potential patient infection. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 25/2/2014 |
