Bartlett, TN, United States
Grace Medical, Inc. recalls
1 recall recorded since 2018, most recently on 3 April 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 3 April 2026
- Reason
- Due to incorrect functional length on device labeling.
- Distribution
- U.S Nationwide distribution in the state of MD.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2308-2026
- TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.