In2bones Usa, Llc: Staple, Fixation, Bone
Recall Summary In2bones USA is recalling NeoSpan SuperElastic Compression Staples (bone fixation devices used in hand and foot surgery) in multiple sizes because the packaging and patient labels are missing the Magnetic Resonance Conditional Symbol, which indicates whether the implant is safe to use during MRI scans. The affected products were distributed across the U.S. and several other countries including Canada, the United Kingdom, and parts of Europe.
- 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 15Wx15x15...
- 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
- FDA-DEVICES
- Recall date
- 2026-05-11
- Status
- Open, Classified
- 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 FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/03f36f5e-12e6-4ca2-b949-b3e799b2baa5