Grace Medical Stapes Prosthesis
Grace Medical is recalling the Titanium/Fluoroplastic Piston Stapes Prosthesis due to incorrect functional length listed on the labeling.
Check your inventory for the affected model. If you have this device in stock, discontinue use and contact Grace Medical for return and replacement instructions.
Why it was recalled
Grace Medical is recalling the Titanium/Fluoroplastic Piston Stapes Prosthesis due to incorrect functional length listed on the device labeling. This discrepancy may lead to improper surgical fit during ear reconstruction procedures.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
- UPC
- 00844505000772
- Recall #
- Z-2308-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification