Exact FDA event identifier

Event 87075

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

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Event summary

Timeline bucket: December 14, 2020
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: K2M, 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

Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System

Z-0931-2021

Recall number: Z-0931-2021
Initiated: December 14, 2020
Classification: Class II
Status: Terminated
Recalling firm: K2M, Inc
Quantity: 248 units/1 each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).

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

The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).

Code information

Product Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582

Distribution pattern

Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore