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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69785

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

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Event summary

Timeline bucket
October 08, 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

Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.

Z-0909-2015
Recall number
Z-0909-2015
Initiated
October 08, 2014
Classification
Class II
Status
Terminated
Recalling firm
Ebi, Llc
Quantity
2816 approx.units ( 2688 units US and 128 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of 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

Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.

Code information

Item Number: 14-571845 5.5 TI 10.5X45MM CANN TRANS 14-571850 5.5 TI 10.5X50MM CANN TRANS 14-571855 5.5 TI 10.5X55MM CANN TRANS 14-571860 5.5 TI 10.5X60MM CANN TRANS 14-571865 5.5 TI 10.5X65MM CANN TRANS 14-571870 5.5 TI 10.5X70MM CANN TRANS 14-571875 5.5 TI 10.5X75MM CANN TRANS 14-571880 5.5 TI 10.5X80MM CANN TRANS 14-571885 5.5 TI 10.5X85MM CANN TRANS 14-571890 5.5 TI 10.5X90MM CANN TRANS 14-571895 5.5 TI 10.5X95MM CANN TRANS 14-571899 5.5 TI 10.5X100MM CANN TRANS

Distribution pattern

Worldwide Distribution: US Distribution to states of: AL, CA, CT, IN, LA, NC, NJ TX & WI; and the country of: The Netherlands.