# FDA recall Z-2355-2026

> **In2bones USA, LLC** · Class II · device recall initiated 2026-05-11.

## 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.

## 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,

## Key facts

- **Recall number:** Z-2355-2026
- **Recalling firm:** In2bones USA, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-11
- **Report date:** 2026-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cordova, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2355-2026

## Citation

> MORVS. FDA recall Z-2355-2026. Retrieved 2026-10-23 from https://api.morvs.ai/recall/Z-2355-2026. Source: US FDA. Licensed CC0.

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