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Recall Observatory FDA recall evidence

Device product

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

November 03, 2020

Class II

Product summary

Firm
K2M, Inc
Event
Event 86748
Status
Terminated
Classification
Class II
Quantity
4 devices
Official record key
device-enforcement:Z-0520-2021

Official wording

Reason: 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.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing nonconformance