Recall Z-2308-2026— Grace Medical, Inc.

Name: FDA recall Z-2308-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-03

Class II · Ongoing

Class II FDA medical device recall by Grace Medical, Inc., initiated 2026-04-03. It names one FDA 510(k) clearance: K060518. Product: TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis. Reason: Due to incorrect functional length on device labeling..

Recalling firm: Grace Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-04-03
Firm location: Bartlett, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K060518 — PARTIAL OSSICULAR REPLACEMENT PROSTHESESGrace Medical, Inc.·cleared 2006-06-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.