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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98978

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 11, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
In2bones USA, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2355-2026
Recall number
Z-2355-2026
Initiated
May 11, 2026
Classification
Class II
Status
Ongoing
Recalling firm
In2bones USA, LLC
Quantity
306 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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,