FDA-Device2026-06-17Class IIMISBRANDING
In2bones NeoSpan SuperElastic Compression Staple recalled for missing MRI safety labeling
In2bones NeoSpan Compression Staple recalled for missing MRI label
In2bones USA has recalled NeoSpan SuperElastic Compression Staples used in hand and foot surgery because the required Magnetic Resonance Imaging (MRI) safety symbol is missing from the product packaging, inner trays, and patient labels. This labeling omission could prevent patients and healthcare providers from knowing whether the implant is safe to use during an MRI scan.
- If you have implanted one of these devices, contact your surgeon or healthcare provider before undergoing an MRI.
- Healthcare facilities should identify affected inventory using the lot codes listed in the FDA notice and quarantine them.
- Surgeons should verify MRI safety information directly with In2bones USA before implanting these devices in new patients.
Hazard
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
Sold states
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,
Affected count
306 kits
Manufactured in
7750a Trinity Rd, N/A, Cordova, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2355-2026Don't want to check this manually?
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