Exact FDA event identifier

Event 84219

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

Open FDA event record

Event summary

Timeline bucket: February 05, 2019
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: SPINEART SA

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

Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures

Z-0546-2020

Recall number: Z-0546-2020
Initiated: February 05, 2019
Classification: Class III
Status: Terminated
Recalling firm: SPINEART SA
Quantity: 14 pieces distribtued to 1 US Distributor

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

label is incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inner blister pack label is incorrect and does not match the correct external box label.

Code information

Model Number: JUT-OX 28 09-S Lot Number: 4-2899 UDI: (01) 0 7640178 97398 5 (11) 181102 (17) 261101 (10) 4-2899

Distribution pattern

US: CA OUS: Unknowns