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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73869

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

Open FDA event record

Event summary

Timeline bucket
April 08, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

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

Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

Z-1602-2016
Recall number
Z-1602-2016
Initiated
April 08, 2016
Classification
Class II
Status
Terminated
Quantity
81 tools

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.

Code information

Product Catalog Number: 10BA40D, Lot Number: H5237248

Distribution pattern

Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.