FDA recall, , Moderate risk
NeoSpan SuperElastic Compression Staple w/Instruments
The NeoSpan SuperElastic Compression Staple w/Instruments is missing the Magnetic Resonance Conditional Symbol on its packaging and labels.
Summary by Recall Canary from the FDA notice
What happened
In2bones USA, LLC, of Cordova, Tennessee, is recalling the NeoSpan SuperElastic Compression Staple w/Instruments because the Magnetic Resonance Conditional Symbol is missing on the carton, inner tray, and patient label. The recall covers 306 kits and was started by the company on May 11, 2026, and added to the FDA's Enforcement Report on June 8, 2026.
The affected products include the NeoSpan SuperElastic Compression Staple w/Instruments in sizes 10x10x10, 12x12x12, and 20x20x20. The products were distributed in the U.S. across states including Alabama, Arizona, California, and others, as well as to Belgium, Canada, Colombia, France, Ireland, Netherlands, Spain, and the United Kingdom. The recall was classified by the FDA on June 8, 2026, and listed in the FDA's weekly enforcement report on June 17, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the lot code and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
T50 SN010 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x10x10
- UDI-DI
- 00817906020083
- Lot code
- T50
- SN010
- 1962242
- 1964665
- 2054541
- 2039361
- SN012
- 1963511
- SN020
- 1971252
- 1990642
- 2027441
- SN110
- 1971241
- SN115
- 19647210
- SN118
- 1990631
T50 SN012 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 12x12x12
- UDI-DI
- 00817906020090
- Lot code
- T50
- SN010
- 1962242
- 1964665
- 2054541
- 2039361
- SN012
- 1963511
- SN020
- 1971252
- 1990642
- 2027441
- SN110
- 1971241
- SN115
- 19647210
- SN118
- 1990631
T50 SN020 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 20x20x20
- UDI-DI
- 00817906020151
- Lot code
- T50
- SN010
- 1962242
- 1964665
- 2054541
- 2039361
- SN012
- 1963511
- SN020
- 1971252
- 1990642
- 2027441
- SN110
- 1971241
- SN115
- 19647210
- SN118
- 1990631
T50 SN110 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x15x13
- UDI-DI
- 00817906020113
- Lot code
- T50
- SN010
- 1962242
- 1964665
- 2054541
- 2039361
- SN012
- 1963511
- SN020
- 1971252
- 1990642
- 2027441
- SN110
- 1971241
- SN115
- 19647210
- SN118
- 1990631
T50 SN115 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 15Wx15x15
- UDI-DI
- 00817906020137
- Lot code
- T50
- SN010
- 1962242
- 1964665
- 2054541
- 2039361
- SN012
- 1963511
- SN020
- 1971252
- 1990642
- 2027441
- SN110
- 1971241
- SN115
- 19647210
- SN118
- 1990631
T50 SN118 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 18x14x14
- UDI-DI
- 00810021861364
- Lot code
- T50
- SN010
- 1962242
- 1964665
- 2054541
- 2039361
- SN012
- 1963511
- SN020
- 1971252
- 1990642
- 2027441
- SN110
- 1971241
- SN115
- 19647210
- SN118
- 1990631
Recall details
- Company began the recall
- Sold in
U.S.: Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, and Wisconsin O.U.S.: Belgium, Canada, Colombia, France, Ireland, Netherlands, Spain, United Kingdom,
- Company
- In2bones USA, LLCCordova, Tennessee
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98978
- Recall number
- Z-2355-2026
- Quantity recalled
- 306 kits
All recalls from In2bones USA, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
