FDA Device recall Z-2308-2026
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
- FDA Device
- Class II
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class II recall of TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis by Grace Medical, citing due to incorrect functional length on device labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2308-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-03 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Grace Medical |
| Distribution | US |
Product
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Reason
Due to incorrect functional length on device labeling.
Identifiers
| code_info | Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2308-2026%22
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