Stapes Prosthesis Recall: Grace Medical piston 409-375
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 |
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.
How to identify the recalled item
| Lot / date codes | Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927 |
|---|---|
| Lot / date codes | Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.