⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Grace Medical, Inc.: TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis

Medical DevicesSource: FDA (device) · Date: 2026-06-10

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Grace Medical, Inc.
Product
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Reason / hazard
Due to incorrect functional length on device labeling.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S Nationwide distribution in the state of MD.
Recall initiated
2026-04-03
Code info
Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927
Product quantity
7
Voluntary mandated
Voluntary: Firm initiated
City
Bartlett
State
TN
Country
United States
Event id
98773
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