FDAFDA · Food and drugs·Recall number Z-2308-2026
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Published June 10, 2026 · Recall initiated: April 3, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to incorrect functional length on device labeling.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Grace Medical, Inc.
- Distributor
- U.S Nationwide distribution in the state of MD.
- Lot
- Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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