The Recall Desk
HighFDA (Devices)·Z-2026-2020·Announced 2020-05-27

K2M Aleutian Lordotic Spreader Recalled for Welded Tip Breakage Risk

K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device that poses a risk of harm during surgery, but the source text does not report specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader, a stainless steel, non-sterile medical device used to simulate cage height and expand spine disc space. The recall is due to a manufacturing defect where the device is constructed as two pieces welded together, a design associated with the spreader tip breaking off during the procedure.

The affected product is identified by Lot # FKXR, Catalog # 5203-90165, and UDI # 10888857108783. The device is available in a size of 28x6mm. Distribution was worldwide, including nationwide distribution in the United States across states such as Colorado, Michigan, Texas, California, New York, Florida, Maryland, Oregon, Kansas, Montana, and Missouri, as well as in Europe.

Healthcare providers and facilities should stop using the affected devices and contact K2M, Inc. for further instructions. Patients who have had this device used in their surgery should consult their healthcare provider if they experience any complications.

The recalled product

Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 10888857108783, Size 28x6mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
Manufacturer
K2M, Inc
Category
Medical Device — Orthopedic Instrument
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot # FKXR

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 24 recalled by K2M, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 24 products in this recall →

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