# FDA recall Z-0520-2021

> **K2M, Inc** · Class II · device recall initiated 2020-11-03.

## 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.

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0520-2021
- **Recalling firm:** K2M, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-03
- **Report date:** 2020-12-09
- **Termination date:** 2021-01-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Leesburg, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0520-2021

## Citation

> AI Analytics. FDA recall Z-0520-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0520-2021. Source: US FDA. Licensed CC0.

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