TITANIUM/FLUOROPLASTIC PISTON 0 — Class II medical device recall Z-2308-2026
Ongoing recall by Grace Medical, Inc., reported 2026-06-10, distributed nationwide. Due to incorrect functional length on device labeling.
| Recall number | Z-2308-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Grace Medical, Inc., Bartlett, TN, United States |
| Recall initiated | 2026-04-03 |
| Classified | 2026-06-04 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 7 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00844505000772 |
| Lot numbers | 122927 |
| Model numbers | 409-375 |
Product
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Reason for recall
Due to incorrect functional length on device labeling.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2308-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.