TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Des
Pending LLM rewrite. Source: FDA_DEVICE Z-2308-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Due to incorrect functional length on device labeling.
The recalled product
- Product
- TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
- Manufacturer
- Grace Medical, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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