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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65429

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

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Event summary

Timeline bucket
May 24, 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

S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA

Z-1665-2013
Recall number
Z-1665-2013
Initiated
May 24, 2013
Classification
Class II
Status
Terminated
Recalling firm
SpineFrontier, Inc.
Quantity
12 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.

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

The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.

Code information

Lot/Serial Numbers: 47175

Distribution pattern

USA Nationwide Distribution including the states of: FL, TX, OK, MO, NJ, MA