Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0520-2021 — 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 spec

U.S. FDA — Device Enforcement · United States · 2020-11-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0520-2021
Date of alert
2020-11-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
K2M, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10888857343948
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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