CLASS II ONGOING Device recall · Reported 10 Jun 2026 · FDA Enforcement Report
Stapes Prosthesis recalled by Grace Medical
Grace Medical is recalling Stapes Prosthesis, distributed nationwide in the US. The recall was initiated on 3 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2308-2026
- FDA event ID
- 98773
- Recalling firm
- Grace Medical, Bartlett, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Apr 2026
- FDA classified
- 4 Jun 2026
- Reported
- 10 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 3 Apr 2026 | Recall initiated by company | |
| 4 Jun 2026 | Classified by FDA | +62 days |
| 10 Jun 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to incorrect functional length on device labeling.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Where it was distributed
U.S Nationwide distribution in the state of MD.
Questions about this recall
Why was it recalled?
Due to incorrect functional length on device labeling.
Which lots are affected?
Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927
Where was it sold?
U.S Nationwide distribution in the state of MD.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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