NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number… — Class II medical device recall Z-2355-2026
Ongoing recall by In2bones USA, LLC, reported 2026-06-17, distributed in AL, AZ, CA, CO, FL, GA, HI, ID…. Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
| Recall number | Z-2355-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | In2bones USA, LLC, Cordova, TN, United States |
| Recall initiated | 2026-05-11 |
| Classified | 2026-06-08 |
| Reported by FDA | 2026-06-17 |
| Distributed | 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 |
| Countries outside the US | BE, CA, CO, ES, FR, GB, IE, NL |
| Quantity | 306 kits |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00810021861364, 00817906020083, 00817906020090, 00817906020113, 00817906020137, 00817906020151 |
| Lot numbers | 1962242, 1963511, 1964665, 19647210, 1971241, 1971252, 1990631, 1990642, 2027441, 2039361, 2054541, SN010, SN012, SN020, SN110, SN115, SN118, T50 |
| Model numbers | 1962242, 1963511, 1964665, 19647210, 1971241, 1971252, 1990631, 1990642, 2027441, 2039361, 2054541, SN010, SN012, SN020, SN110, SN115, SN118, T50 |
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 for recall
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2355-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.