TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
USTITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Recalling Firm: Grace Medical, Inc.
Reason for Recall / Hazard
Due to incorrect functional length on device labeling.
Product Description & Identification
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Affected Products
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Additional Source Details
| Field | Value |
|---|---|
| City | Bartlett |
| State | TN |
| Event id | 98773 |
| Address 1 | 8500 Wolf Lake Dr Ste 110 |
| Code info | Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927 |
| Postal code | 38133-4104 |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 7 |
| Reason for recall | Due to incorrect functional length on device labeling. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260403 |
| Initial firm notification | Letter |
| Center classification date | 20260604 |
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Overview
- Recalling FirmGrace Medical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionU.S Nationwide distribution in the state of MD.
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🚨 SAFETY ALERT: Grace Medical, Inc. - TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis Check if your household is affected: https://therecallfile.com/recalls/titanium-fluoroplastic-piston-0-6mm-dia-x-3-75mm-l-model-catalog-numbe/FDA-Z-2308-2026
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