Stapes Prosthesis Recall: Grace Medical piston 409-375
Announced 2026-06-10 · FDA
Grace Medical, Inc. is recalling seven units of its TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L stapes prosthesis (Model 409-375). The recall is due to incorrect functional length on device labeling. The affected units were distributed nationwide in the U.S., including Maryland; the recall involves lot number 122927 and a UDI code (01)00844505000772(10)122927(17)310301.
| Brand | Grace Medical, Inc. |
|---|---|
| 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. |
| Severity | moderate |
| Units affected | 7 |
| Distribution | U.S Nationwide distribution in the state of MD. |
| Agency | FDA |
| Recall / campaign no. | Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927 |
WHAT YOU SHOULD DO
- Check if you have the recalled device (Model 409-375) implanted or in your possession and contact your surgeon or healthcare provider.
- Do not use or implant any affected devices; follow your provider's guidance for evaluation or replacement.
- Follow recall instructions from Grace Medical and the FDA, and return or communicate as directed.
- If you have symptoms or concerns, seek medical attention and report them to your healthcare provider.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.