Device recall

Z-0520-2021: Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The…

FDA device recall · Class II · K2M, Inc

Key facts

Recall number (Z-number) Z-0520-2021
Recall event 86748
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…
Product code NKG
Recalling firm K2M, Inc
Recall class Class II
Status Terminated
Termination date Jan 12, 2021
510(k) numbers K193129
FEI number 3008599177

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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