Device product
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Z-2308-2026
Product summary
- Event
- Event 98773
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7
- Official record key
device-enforcement:Z-2308-2026
Official wording
Reason: Due to incorrect functional length on device labeling.
Code information: Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927
Distribution pattern: U.S Nationwide distribution in the state of MD.
Derived failure modes
-
Unknown
Due to incorrect functional length on device labeling.