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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69981

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

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Event summary

Timeline bucket
November 11, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ebi, 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

Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Z-0874-2015
Recall number
Z-0874-2015
Initiated
November 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Ebi, Llc
Quantity
193 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments (the Sleeves) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments (the Sleeves) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.

Code information

Part number 14-531593 Part number 14-531594 Catalog number Lot Number 14-531593 N23597 14-531594 N23599

Distribution pattern

US Nationwide Distribution.