Recall archive / FDA device enforcement
NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElasti... — FDA record Z-2355-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 11, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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/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.
- Reason
- Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
- Classification
- Class II
- Recalling firm
- In2bones USA, LLC
- Quantity
- 306 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2355-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog No. Lot Code T50 SN010 1962242 1964665 2054541 2039361 T50 SN012 1963511 T50 SN020 1971252 1990642 2027441 T50 SN110 1971241 T50 SN115 19647210 T50 SN118 1990631 |
Match all identifying details in the current notice. A brand name alone is not enough.
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,
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 17, 2026
- Recall initiation date
- May 11, 2026
- Center classification date
- Jun 8, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.