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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65442

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

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Event summary

Timeline bucket
May 07, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SpineFrontier, Inc.

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

InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.

Z-1666-2013
Recall number
Z-1666-2013
Initiated
May 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
SpineFrontier, Inc.
Quantity
61 individual inserter assemblies

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for set screw to be come deformed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

Potential for set screw to be come deformed.

Code information

Right Assembly: 43097, 44614, 43097R; Left Assembly: 43098, 44615, 43098R

Distribution pattern

Worldwide Distribution - USA Nationwide: in the states of: FL, CO, VA, KS, TX, OH, TN, OK, CA, IL, MO, MN, Wash DC, including PR and the countries of Dominican Republic, Medico, Panama

Field note

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