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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78592

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

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Event summary

Timeline bucket
November 13, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Amendia, Inc dba Spinal Elements

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

Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).

Z-0239-2018
Recall number
Z-0239-2018
Initiated
November 13, 2017
Classification
Class II
Status
Terminated
Quantity
82 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.

Code information

Part No. CSF-40-12, Lot No. 132635

Distribution pattern

US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.