Class II — Grace Medical, Inc.
| Recalling firm | GRACE MEDICAL GROUP, INC. |
|---|---|
| Registered facility | GRACE MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to incorrect functional length on device labeling. |
| Product | TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis |
| Quantity | 7 |
| Distribution | U.S Nationwide distribution in the state of MD. |
| Initiated | 2026-04-03 |
| Classified | 2026-06-04 |
| Recall number | Z-2308-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Grace Medical, Inc. (Z-2308-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98773/
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