FDA recall Z-2308-2026

Grace Medical, Inc. · Class II · device

Product

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

Reason for recall

Due to incorrect functional length on device labeling.

Distribution

U.S Nationwide distribution in the state of MD.

Key facts

Status
Ongoing
Initiation date
2026-04-03
Report date
2026-06-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bartlett, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2308-2026