Exact FDA event identifier

Event 68526

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

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Event summary

Timeline bucket: May 15, 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

Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.

Z-1811-2014

Recall number: Z-1811-2014
Initiated: May 15, 2014
Classification: Class II
Status: Terminated
Recalling firm: Ebi, Llc
Quantity: 32 units (30 domestic and 2 international)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

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Inspect official wording and provenance

Reason for recall

The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.

Code information

Catalog Number 14-501669; Lot Number 006731

Distribution pattern

Worldwide Distribution - USA (nationwide) and the country The Netherlands.