# FDA recall Z-2012-2020

> **K2M, Inc** · Class II · device recall initiated 2020-04-13.

## Product

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90115, UDI # 10888857108288, Size 24x12mm, 6  Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.

## Reason for recall

The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of Colorado, Michigan, Texas, California, New York, Florida, Maryland, Oregon, Kansas, Montana, Missouri and the country of Europe.

## Key facts

- **Recall number:** Z-2012-2020
- **Recalling firm:** K2M, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-13
- **Report date:** 2020-05-27
- **Termination date:** 2021-11-15

- **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-2012-2020

## Citation

> AI Analytics. FDA recall Z-2012-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2012-2020. Source: US FDA. Licensed CC0.

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