Titanium/Fluoroplastic Piston 0.6mm Dia X 3.75mm L recallZ-2308-2026 · Grace Medical, Inc. · initiated Apr 3, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Grace Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to incorrect functional length on device labeling.
FDA root cause category: Process control
What the company is doing
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].
Recall details
- Recall number
- Z-2308-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 3, 2026
- Posted by the FDA
- Jun 4, 2026
- Recalling firm
- Grace Medical, Inc.
- Quantity
- 7
- Product code
- ETB
- FDA submissions
- K060518
- Distribution
- U.S Nationwide distribution in the state of MD.
Product description
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Code information (models, lots, serial numbers)
Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TITANIUM/FLUOROPLASTIC PISTON 409-375Grace Medical, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K060518 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- GRACE MEDICAL FLUOROPLASTIC PISTON 402-450Grace Medical, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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