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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86748

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

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Event summary

Timeline bucket
November 03, 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 OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque.

Z-0520-2021
Recall number
Z-0520-2021
Initiated
November 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
K2M, Inc
Quantity
4 devices

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing nonconformance

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.

Code information

Catalog Number/REF 7601-90001 LOT KTGG GTIN 10888857343948

Distribution pattern

US Nationwide distribution.