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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66098

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

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Event summary

Timeline bucket
August 13, 2013
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

Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662

Z-2214-2013
Recall number
Z-2214-2013
Initiated
August 13, 2013
Classification
Class II
Status
Terminated
Recalling firm
Ebi, Llc
Quantity
427 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.

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

Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.

Code information

14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029 14-501661 Rod Reducer Lots IT0015 IT0022 IT0023 14-501662 Counter Torque Lots IT0020 IT0021

Distribution pattern

Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.