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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71297

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

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Event summary

Timeline bucket
May 18, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Orthofix, 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

ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse

Z-1749-2015
Recall number
Z-1749-2015
Initiated
May 18, 2015
Classification
Class II
Status
Terminated
Recalling firm
Orthofix, Inc
Quantity
45 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm.

Code information

Lot Number S29

Distribution pattern

US Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain.