Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26296 |
| Brand Name: | Gyrus_ENT Pistons |
| Model: | SMARTTM STAPES PISTON 0.4 mm x 5.25 mm - Lot number PR898678 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Olympus (NZ) Ltd 15D Paul Matthews Road Albany Auckland |
| Contact Information: | 0508 659 6787 |
| Manufacturer: | Gyrus ACMI Inc |
| Issue: | The manufacturer has identified that a quantity of Stapes Piston was packaged with the outer carton label stating the contents were the 70143662 Smart Piston, but the inside package contents was the 70142168 Stapes Piston. Insertion of an incorrect length Smart Piston could reduce the effectiveness of the implant in conductive hearing. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/7/2020 |
