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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96179

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

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Event summary

Timeline bucket
January 03, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
XTANT Medical Holdings, 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

Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))

Z-1177-2025
Recall number
Z-1177-2025
Initiated
January 03, 2025
Classification
Class II
Status
Ongoing
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.

Code information

Model X080-382819-08PC-STR: UDI-DI M697X08038281908PCSTR1, Lot Number 054961; Model Number X080-423011-08PC-STR: UDI-DI: M697X08042301108PCSTR1, Lot Number 053028

Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.