Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Recalled by K2M, Inc Due to Shafts do not pass through the inner cannula...

Date: November 3, 2020
Company: K2M, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact K2M, Inc directly.

Affected Products

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.

Quantity: 4 devices

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About K2M, Inc

K2M, Inc has 38 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report