Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16554 |
| Brand Name: | Cochlear Soft Tissue Gauge |
| Model: | 95070 |
| Affected: | 131008 |
| Software version: | |
| Recalling Organisation: | Cochlear NZ Limited C/- KPMG 18 Viaduct Harbour Ave Auckland 1010 |
| Contact Information: | |
| Manufacturer: | Cochlear Bone Anchored Solutions AB |
| Issue: | Manufacturer informed of a potential quality issue with the product. A Health Risk Assessment was performed and the following potential risks were identified: 1. Metal fragement comes loose and ends up on/ under the patient's skin during surgery casuing an inflammatory response 2. Endotocins lefton instrument after cleaning and sterilisation 3.Metal fragment/ sharp edge (causing additional scratches to soft tissue during surgery.) |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/4/2014 |
