# FDA recall Z-0931-2021

> **K2M, Inc** · Class II · device recall initiated 2020-12-14.

## Product

Yukon Polyaxial Screw Size  4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System

## Reason for recall

The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).

## Distribution

Domestic: Nationwide     Foreign: Australia, Canada, Netherlands, Singapore

## Key facts

- **Recall number:** Z-0931-2021
- **Recalling firm:** K2M, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-14
- **Report date:** 2021-02-03
- **Termination date:** 2023-07-11

- **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-0931-2021

## Citation

> AI Analytics. FDA recall Z-0931-2021. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-0931-2021. Source: US FDA. Licensed CC0.

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