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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97265

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

Open FDA event record

Event summary

Timeline bucket
June 24, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Orthofix U.S. 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

PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP

Z-2555-2025
Recall number
Z-2555-2025
Initiated
June 24, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Orthofix U.S. LLC
Quantity
3

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling discrepancy with incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.

Code information

UDI-DI: 18257200161010, Lots: 001, 002, and 003

Distribution pattern

US Nationwide distribution in the states of CO, CA.