Device product
Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
Z-2813-2020
Product summary
- Event
- Event 86045
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 units
- Official record key
device-enforcement:Z-2813-2020
Official wording
Reason: Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below
Code information: Lot number: PR898678
Distribution pattern: CA , FL , GA , PA Foreign: New Zealand , Switzerland
Derived failure modes
-
Labeling or packaging
Mislabeled