Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93647

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

Open FDA event record

Event summary

Timeline bucket
December 07, 2023
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Globus Medical, Inc.

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

ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

Z-0642-2024
Recall number
Z-0642-2024
Initiated
December 07, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Globus Medical, Inc.
Quantity
9

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.

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

A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.

Code information

UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109

Distribution pattern

Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.