Z-2308-2026 Class II Ongoing

Recalled by Grace Medical, Inc. — Bartlett, TN

Recall Details

Product Type
Devices
Report Date
June 10, 2026
Initiation Date
April 3, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7

Product Description

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 Pattern

U.S Nationwide distribution in the state of MD.

Code Information

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