TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
FDA Recall Z-2308-2026 · Posted 2026-06-04
Advertisement
Recalling FirmGrace Medical, Inc.
Recall StatusOpen, Classified
Product CodeETB
Date Initiated2026-04-03
Product Quantity7
Reason for Recall
Due to incorrect functional length on device labeling.
Firm Action
On 04/03/2026, the firm emailed a "RECALL NOTICE" to it single customer informing them that the firm determined the pistons were manufactured with an incorrect functional length. Devices are labeled as 3.75 mm but have an actual functional length of 4.00 mm.
The customer was instructed to:
" Immediately discontinue use and quarantine affected product
" Return affected product using the provided RMA
" If any devices have been used, provide the date(s) of surgery on the response form
" Complete and return the enclosed Recall Response Form
For questions - contact Grace Medical at 901-386-0990 or [email protected].
Root Cause
Process control
Distribution Pattern
U.S Nationwide distribution in the state of MD.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement