Class II — In2bones USA, LLC
| Recalling firm | In2Bones USA, LLC |
|---|---|
| Registered facility | IN2BONES USA, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. |
| 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 12x12x12 UDI-DI Code: 00817906020090 T50 SN020 NeoSpan® SuperElastic Compression Staple w/Instruments, Size 20x20x20 UDI-DI Code: 00817906020151 T50 SN110 NeoSpan® SuperElastic Compression Staple w/Instruments, Size 10x15x13 UDI-DI Code: 00817906020113 T50 SN115 NeoSpan® SuperElastic Compression Staple w/Instrumen… |
| Quantity | 306 kits |
| Distribution | U.S.: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MD, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, and WI O.U.S.: Belgium, Canada, Colombia, France, Ireland, Netherlands, Spain, United Kingdom, |
| Initiated | 2026-05-11 |
| Classified | 2026-06-08 |
| Recall number | Z-2355-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — In2bones USA, LLC (Z-2355-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98978/
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