FDA recall, , Moderate risk
Grace Medical Stapes Prosthesis
The stapes prosthesis has incorrect functional length on its labeling.
Summary by Recall Canary from the FDA notice
What happened
Grace Medical, Inc., of Bartlett, Tennessee, recalled its Titanium/Fluoroplastic Piston 0.6MM Dia X 3.75MM L, a stapes prosthesis, because the device labeling has an incorrect functional length. The recall began on April 3, 2026, and was added to the FDA's Enforcement Report on June 4, 2026. The product was distributed in the state of Maryland.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Titanium/Fluoroplastic Piston 0.6MM DIA X 3.75MM L
- Model number
- 409-375
- UDI-DI
- 00844505000772
- Lot code
- 122927
Recall details
- Company began the recall
- Sold in
U.S Nationwide distribution in the state of Maryland.
- Company
- Grace Medical, Inc.Bartlett, Tennessee
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98773
- Recall number
- Z-2308-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
