[pending] NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010
Pending LLM rewrite. Source: FDA_DEVICE Z-2355-2026.
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 the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
The recalled product
- Product
- NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 SN012 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 12x12x1
- Manufacturer
- In2bones USA, LLC
- Category
- Medical Device — Devices
Distribution
Distributed in 25 states:
- AL
- AZ
- CA
- CO
- FL
- GA
- HI
- ID
- IL
- IN
- LA
- MD
- MO
- NC
- NJ
- NV
- NY
- OH
- OK
- PA
- TN
- TX
- UT
- VA
- WI
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