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Grace Medical Stapes Prosthesis
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MEDICAL DEVICE RECALLMODERATE

Grace Medical Stapes Prosthesis

Grace Medical is recalling the Titanium/Fluoroplastic Piston Stapes Prosthesis due to incorrect functional length listed on the labeling.

What to do

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.

Recalled
Listed
Updated
Recall No.
Z-2308-2026
Agency
FDA
Firm
Grace Medical, Inc.
Recall ID
98773
Status
ONGOING

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

Lot code
122927
UDI-DI
00844505000772

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification