NeoSpan SuperElastic Compression Staple
In2bones USA is recalling 10+ variants of NeoSpan compression staples due to missing MR Conditional safety labeling.
Contact your healthcare provider or the facility where the procedure was performed if you have questions regarding the MR safety status of your implanted device.
Why it was recalled
In2bones USA is recalling 10+ variants of NeoSpan SuperElastic Compression Staple w/Instruments due to the absence of the Magnetic Resonance (MR) Conditional symbol on the carton, inner tray, and patient label. The full list of affected catalog numbers is available on the FDA recall page.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| 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 10x | 19647210 | Z-2355-2026 |
| 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/Instruments, Size 15Wx15x15 UDI-DI Code: 00817906020137 T50 SN118 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 18x14x14 UDI-DI Code: 00810021861364 Single/multiple component metallic bone fixation appliances and accessories The In2Bones USA NeoSpan" Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis. | – | – |
Where it was sold
Distributed in Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, and Wisconsin.
Official source
Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification