Grace Medical, Inc. recalls TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L
- Recalling company
- Grace Medical, Inc.
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 3, 2026
- Reported
- Jun 10, 2026
- Distribution
- U.S Nationwide distribution in the state of MD.
- Status
- Ongoing
- Quantity
- 7
- Lot / codes
- Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927
- Company location
- Bartlett, TN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2308-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2308-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.