[pending] 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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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