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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92749

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

Open FDA event record

Event summary

Timeline bucket
July 12, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Sofamor Danek USA, 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

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

Z-2363-2023
Recall number
Z-2363-2023
Initiated
July 12, 2023
Classification
Class II
Status
Ongoing
Quantity
13 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect Laser Marking - Solera Awl Tip Tap

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect Laser Marking - Solera Awl Tip Tap

Code information

SOLERA AWLTIPTAP (REF NAV2006K GTIN 00643169540958, Batch CA21L046). The Component (CFN NAV2006K) is packaged inside the SOLERA TAPS Kit (REF 9735465, GTIN 00763000564087), Lot Numbers: 0011743681, 0011734643, 0011713764, 0011722871, 0011705200

Distribution pattern

US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.