Exact FDA event identifier

Event 65999

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

Open FDA event record

Event summary

Timeline bucket: July 31, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Spine Smith Holdings, 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

VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.

Z-2258-2013

Recall number: Z-2258-2013
Initiated: July 31, 2013
Classification: Class II
Status: Terminated
Recalling firm: Spine Smith Holdings, LLC
Quantity: 32

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The product has the potential to be laser marked as a Medium when it actually is a Small.

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

The product has the potential to be laser marked as a Medium when it actually is a Small.

Code information

Part Number: 0301-1410, Lot 53AR

Distribution pattern

Distributed in FL.