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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80012

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

Open FDA event record

Event summary

Timeline bucket
April 09, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
VGI Medical, 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

VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

Z-2100-2018
Recall number
Z-2100-2018
Initiated
April 09, 2018
Classification
Class II
Status
Terminated
Recalling firm
VGI Medical, LLC
Quantity
6 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cleaning process for the VerteLP Instrument Tray that was not validated

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated

Code information

Lots of Instrument Sets: LP-INSTSET-001, VLP-INSTSET-002, VLP-INSTSET-003, VLP-INSTSET-004, VLP-INSTSET-005, VLP-INSTSET-006. Lots of individual instruments contained in sets: 127617, 127901, 127902, 127903, 127904, 127905, 127906, 127907, 127908, 133003, 133004, 133005, 1330-1, 1330-2, 1330-6, 133004, 1285001, 144301, 144302, 163214, 1401001, 157801, 162402 163203, 163204, 163205, 163206, 163207, 163208, 163209, 163212, 163213, and 163214.

Distribution pattern

Distributed to MI, FL, and NY.