Z-2308-2026Class II

Grace Medical, Inc.

Recalling firm

Grace Medical, Inc.

Product type

Device

Status

Ongoing

Report date

2026-06-10

Distribution

U.S Nationwide distribution in the state of MD.

Firm state

Product quantity

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

Due to incorrect functional length on device labeling.

Product description

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

Code / lot info

Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.