United StatesThe TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L stapes prosthesis (Model/Catalog 409-375, Lot 122927) distributed in Maryland, United States, is being recalled. It was recalled because the device labeling shows an incorrect functional length.
What's being recalled
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Recalling firm: Grace Medical, Inc., Bartlett, TN, United States.
How to identify it
Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927
The hazard
Due to incorrect functional length on device labeling.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S Nationwide distribution in the state of MD.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)