CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report

NeoSpan¿ SuperElastic Compression Staple w/Instruments recalled

In2bones USA is recalling NeoSpan¿ SuperElastic Compression Staple w/Instruments, distributed in 25 states. The recall was initiated on 11 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog No. Lot Code T50 SN010 1962242 1964665 2054541 2039361 T50 SN012 1963511 T50 SN020 1971252 1990642 2027441 T50 SN110 1971241 T50 SN115 19647210 T50 SN118 1990631

Quantity recalled306 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2355-2026
FDA event ID: 98978
Recalling firm: In2bones USA, Cordova, TN
Classification: Class II
Status: Ongoing
Recall initiated: 11 May 2026
FDA classified: 8 Jun 2026
Reported: 17 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

11 May 2026	Recall initiated by company
8 Jun 2026	Classified by FDA	+28 days
17 Jun 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

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,

Alabama Arizona California Colorado Florida Georgia Hawaii Idaho Illinois Indiana Louisiana Maryland Missouri North Carolina New Jersey Nevada New York Ohio Oklahoma Pennsylvania

Questions about this recall

Is NeoSpan¿ SuperElastic Compression Staple w/Instruments recalled?

Yes. In2bones USA recalled NeoSpan¿ SuperElastic Compression Staple w/Instruments on 11 May 2026. The recall is Class II and its status is Ongoing. Recall number Z-2355-2026.

Why was it recalled?

Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.

Which lots are affected?

Catalog No. Lot Code T50 SN010 1962242 1964665 2054541 2039361 T50 SN012 1963511 T50 SN020 1971252 1990642 2027441 T50 SN110 1971241 T50 SN115 19647210 T50 SN118 1990631

Where was it sold?

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,

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from In2bones USA

All 5

Reported	Class	Recall	Company	Reason	Where
29 Sep 2021Device	CLASS II	CoLink Bone Graft Harvester, Sterile, Disposable recalled	In2bones USA	E. coli	Nationwide
2 Jan 2019Device	CLASS II	NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10 recalled	In2bones USA	Other	11 states
29 Aug 2018Device	CLASS II	CoLink(TM) Lapidus Plate XP, +, Left recalled by In2bones USA	In2bones USA	Other	Nationwide
29 Aug 2018Device	CLASS II	CoLink(TM) Lapidus Plate XP, +, Right recalled by In2bones USA	In2bones USA	Other	Nationwide

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