TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 ... recall (Grace Medical, Inc.)
Medical deviceClass IIOngoing
Summary: Grace Medical, Inc. is recalling 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.
What is being recalled
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Why
Due to incorrect functional length on device labeling.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S Nationwide distribution in the state of MD. (states named: Maryland)
How to tell if yours is affected
Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2308-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 3, 2026 |
| Reported | June 10, 2026 |
| Company | Grace Medical, Inc. |
| Company location | Bartlett, TN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7 |
More recalls from Grace Medical, Inc. · all medical device recalls · recalls from April 2026