Recall Z-2355-2026
- Recall number
- Z-2355-2026
- Event number
- 98978
- Firm
- In2bones USA, LLC
- Firm FEI
- 3011580264
- Product code
- JDR
- Status
- Open, Classified
- Initiated
- 2026-05-11
- Posted
- 2026-06-08
- Root cause
- Process control
- 510(k) numbers
- K161426, K232990, K012081, K191463, K210482, K000797, K203832, K942889, K041115, K151160, K926270, K011716, K221947, K041065, K911031, K792204, K041988, K102143, K811500, K896471, K232324, K830455, K981798, K853704, K231458, K062734, K965175, K897155, K131061, K853267
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.