FDAHealthApril 3, 2026
Grace Medical, Inc. — TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
⚠️ Due to incorrect functional length on device labeling.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 3, 2026
U.S Nationwide distribution in the state of MD.
What's affected?
- Product
- TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
- Brand
- Grace Medical, Inc.
- Lot code
- 122927
Additional details
Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7.
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