Class II
Medical Device Recall: TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Grace Medical, Inc. · April 3, 2026
Reason for Recall
Due to incorrect functional length on device labeling.
Distribution
U.S Nationwide distribution in the state of MD.
States Affected
NATIONWIDE
Quantity Affected
7
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2308-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.