FDA Medical devices recall ·
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model recall
- Recall number
- Z-2308-2026
- Date
- (initiated April 3, 2026)
- Company / brand
- Grace Medical, Inc.
8500 Wolf Lake Dr Ste 110, Bartlett, TN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Why was it recalled?
Due to incorrect functional length on device labeling.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927
Distribution
U.S Nationwide distribution in the state of MD.
States: Maryland
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2308-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.