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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67203

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

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Event summary

Timeline bucket
January 03, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
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

SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.

Z-0866-2014
Recall number
Z-0866-2014
Initiated
January 03, 2014
Classification
Class II
Status
Terminated
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Reprocessing Controls

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.

Code information

TI13J01811

Distribution pattern

US Distribution in the states of CA, NC, TX, IN, NJ, and MI.