Z-2308-2026Class II

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

Name: Z-2308-2026 TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes...
Creator: Grace Medical, Inc.
Published: 2026-04-03
License: https://open.fda.gov/license/

Grace Medical, Inc. / initiated 2026-04-03 / Open, Classified / root cause: manufacturing process

FDA source

Grace Medical, Inc. began a recall of TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis on 2026-04-03. FDA classified it as Class II and gives the reason as "Due to incorrect functional length on device labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2308-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-03
Posted: 2026-06-04
Recalling firm: Grace Medical, Inc.
Product: TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Product code: ETB Prosthesis, Partial Ossicular Replacement
Reason for recall: Due to incorrect functional length on device labeling.
Root cause tag: manufacturing process
FDA root cause: Process control
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].
Quantity in commerce: 7
Distribution: U.S Nationwide distribution in the state of MD.
Product codes and lots: Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2308-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2308-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-04

Product code ETB

K060518Class IIPartial Ossicular Replacement ProsthesesGrace Medical, Inc. / cleared 2006-06-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)