Reported Jun 10, 2026 · Ongoing
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Grace Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Grace Medical, Inc. · 8500 Wolf Lake Dr Ste 110 · Bartlett, TN · 38133-4104
Is this the product you have?
- TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM
- L Model/Catalog Number409-375
- Product DescriptionStapes Prosthesis
- Lot codes and dates
- Model/Catalog Number409-375
- UDI code(01)00844505000772(10)122927(17)310301
- Lot Number122927
- Amount recalled
- 7
Where it was sold
- Nationwide
- MD
Why it was recalled
Due to incorrect functional length on device labeling.
This product could cause temporary or reversible health problems — stop using it.
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