In2bones Usa, Llc: Neospan¿ Superelastic Compression Staple W/instruments
NeoSpan SuperElastic Compression Staple Recall Summary In2bones USA is recalling several sizes of NeoSpan SuperElastic Compression Staples with instruments, which are metallic implants used to fix bone fragments and joints in hand and foot surgery. The recall was issued because the product packaging and labels are missing the Magnetic Resonance Conditional Symbol, which indicates whether the device is safe to use during MRI scans. The affected devices were distributed across multiple U.S. states and several international countries including Canada, the United Kingdom, France, and others.
- Recalling firm
- In2bones USA, LLC
- 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...
- Reason
- Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-11
- Status
- Ongoing
- Areas affected
- AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MD, ...
- 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,
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/1d11a9b8-3daf-48d9-81c9-4b9f2f24503d