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NeoSpan SuperElastic Compression Staple
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MEDICAL DEVICE RECALLMODERATE

NeoSpan SuperElastic Compression Staple

In2bones USA is recalling 10+ variants of NeoSpan compression staples due to missing MR Conditional safety labeling.

What to do

Contact your healthcare provider or the facility where the procedure was performed if you have questions regarding the MR safety status of your implanted device.

Recalled
Listed
Updated
Recall No.
Z-2355-2026
Agency
FDA
Firm
In2bones USA, LLC
Recall ID
98978
Status
ONGOING

Recall at a glance

Quantity recalled
306 kits

Why it was recalled

In2bones USA is recalling 10+ variants of NeoSpan SuperElastic Compression Staple w/Instruments due to the absence of the Magnetic Resonance (MR) Conditional symbol on the carton, inner tray, and patient label. The full list of affected catalog numbers is available on the FDA recall page.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeUDI-DI
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 10x–19647210
T50 SN010 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x10x10T50, SN010, 1962242, 1964665, 2054541, 2039361, SN012, 1963511, SN020, 1971252, 1990642, 2027441, SN110, 1971241, SN115, 19647210, SN118, 199063100817906020083
T50 SN012 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 12x12x12T50, SN010, 1962242, 1964665, 2054541, 2039361, SN012, 1963511, SN020, 1971252, 1990642, 2027441, SN110, 1971241, SN115, 19647210, SN118, 199063100817906020090
T50 SN020 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 20x20x20T50, SN010, 1962242, 1964665, 2054541, 2039361, SN012, 1963511, SN020, 1971252, 1990642, 2027441, SN110, 1971241, SN115, 19647210, SN118, 199063100817906020151
T50 SN110 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x15x13T50, SN010, 1962242, 1964665, 2054541, 2039361, SN012, 1963511, SN020, 1971252, 1990642, 2027441, SN110, 1971241, SN115, 19647210, SN118, 199063100817906020113
T50 SN115 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 15Wx15x15T50, SN010, 1962242, 1964665, 2054541, 2039361, SN012, 1963511, SN020, 1971252, 1990642, 2027441, SN110, 1971241, SN115, 19647210, SN118, 199063100817906020137
T50 SN118 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 18x14x14T50, SN010, 1962242, 1964665, 2054541, 2039361, SN012, 1963511, SN020, 1971252, 1990642, 2027441, SN110, 1971241, SN115, 19647210, SN118, 199063100810021861364

Where it was sold

Distributed in 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.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Labeling Error recalls

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification