K2M, Inc: Medical Device Recall in 2020 - (Recall #: Z-0520-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 3, 2020

Date Posted: December 9, 2020

Recall Number: Z-0520-2021

Event ID: 86748

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.

Status: Terminated

Product Quantity: 4 devices

Code Information:

Catalog Number/REF 7601-90001 LOT KTGG GTIN 10888857343948

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated