Class II U.S. Food and Drug Administration

In2bones USA, LLC NeoSpan¿ SuperElastic Compression Staple w/Instruments recall: Due to the Magnetic Resonance Conditional Symbol missing on the carton

Recall published 4 months ago

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

The hazard: Foreign material — foreign objects

The company found foreign objects in the product, or a customer did. Either way the recall covers every pack from the runs listed, because contamination of this kind is rarely confined to one unit.

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

Why it matters: Pieces of foreign objects may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: whether it shows up on imaging depends entirely on the material, so describe the product and the notice to them.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2355-2026
Published
June 17, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
In2bones USA, LLC
Product type
Medical devices
Units affected
306 kits
Distribution
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, Wisconsin
Made in
United States
Lot / code info
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
UPC codes
00817906020083, 00817906020090, 00817906020151, 00817906020113, 00817906020137, 00810021861364

Products covered by this recall

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.

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00817906020083
  • 00817906020090
  • 00817906020151
  • 00817906020113
  • 00817906020137
  • 00810021861364

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Foreign material

In2bones USA, LLC — The company found foreign objects in the product, or a customer did. Either way the recall covers every pack from the runs listed, because contamination of this kind is rarely confined to one unit.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. Keep the pack if you can. If anyone was hurt, the fragment and the packaging together are the evidence that matters.
  3. Return it to the store or bin it sealed, and claim the refund using the lot code from the label.
  4. Check the freezer and the pantry for other packs carrying the same codes before you consider the matter closed.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Company contact: In2bones USA, LLC — 7750a Trinity Rd, Cordova, TN, 38018-2722

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was In2bones USA, LLC medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00817906020083, 00817906020090, 00817906020151. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Which states were affected?

The notice lists Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Louisiana, Maryland and others.

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