The Recall Desk
HighFDA (Devices)·Z-2014-2020·Announced 2020-05-27

K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

K2M, Inc. is recalling the Aleutian Interbody Spacer Systems 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 is classified as FDA Class II. The hazard involves a structural failure of a medical instrument during a procedure, which is a risk-of-harm product where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

K2M, Inc. is recalling the Aleutian Interbody Spacer Systems, specifically the EN AN Lordotic Spreader (Catalog # 5203-90123, UDI # 10888857108363, Size 24x6mm). The product is a stainless steel, non-sterile instrument used to simulate the height of a cage and expand the spine disc space to determine the optimal implant size based on patient anatomy.

The recall is due to a manufacturing defect where the spreader, which is manufactured as two pieces welded together, has been associated with the spreader tip breaking off during the procedure. This defect poses a risk of the instrument failing while in use.

The affected product is Lot # FKXC. Distribution was worldwide, including US nationwide distribution in 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 spreaders and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 10888857108363, Size 24x6mm, 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 — Surgical 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 # FKXC

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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