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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81655

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

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Event summary

Timeline bucket
November 14, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
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, Size 10x10x10, Part Number T50 SN010

Z-0670-2019
Recall number
Z-0670-2019
Initiated
November 14, 2018
Classification
Class II
Status
Terminated
Recalling firm
In2bones USA, LLC
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit.

Code information

Lot Number: 9G88C0

Distribution pattern

TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA