# FDA recall Z-1307-2022

> **K2M, Inc.** · Class II · device recall initiated 2022-06-13.

## Product

Yukon Straight Rod  4.0 x120mm;  Cat# 7601-540120.  Used to provide immobilization and stabilization of spinal segments.

## Reason for recall

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.

## Distribution

Domestic distribution to FL  GA  NE NV  NY  OH OK  SC  Foreign distribution to Canada, EU, and Hong Kong.

## Key facts

- **Recall number:** Z-1307-2022
- **Recalling firm:** K2M, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-13
- **Report date:** 2022-07-06

- **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-1307-2022

## Citation

> AI Analytics. FDA recall Z-1307-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1307-2022. Source: US FDA. Licensed CC0.

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