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 Straight Rod 4.0 x120mm Recalled by K2M, Inc. Due to Some of the rods in this lot were...

Date: June 13, 2022
Company: K2M, Inc.
Status: Ongoing
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 Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.

Quantity: 53 devices (19 US; 34 OUS)

Why Was This Recalled?

Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue.

Where Was This Sold?

This product was distributed to 8 states: FL, GA, NE, NV, NY, OH, OK, SC

Affected (8 states)Not affected

About K2M, Inc.

K2M, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

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