FDA Enforcement
Class II
Ongoing
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Recall: Z-2308-2026
·
Reported June 10, 2026
Enforcement
- Recall Number
- Z-2308-2026
- Event ID
- 98773
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Grace Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 10, 2026
- Initiation Date
- April 3, 2026
- Classification Date
- June 4, 2026
- Address
- 8500 Wolf Lake Dr Ste 110, Bartlett, TN, 38133-4104, United States
Description
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Reason
Due to incorrect functional length on device labeling.
Code Info
Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927
Distribution
U.S Nationwide distribution in the state of MD.
Quantity
7