Agency classClass IIOur severity:High FDA (Devices)·Z-2020-2020·Announced 2020-05-27

K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 any specific injuries or illnesses, meeting the criteria for a High severity score.

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 welded pieces, a design associated with the spreader tip breaking off during the procedure.

The affected product is identified by Catalog # 5203-90149, UDI # 10888857108622, Size 28x4mm, and Lot # FKXJ. Distribution was worldwide, including nationwide distribution in the United States and in Europe. The source text does not specify the number of units affected or report any specific injuries or illnesses.

Healthcare providers and patients should stop using the affected devices and contact K2M, Inc. for further instructions on returns or replacements.

The recalled product

Product: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Size 28x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Manufacturer: K2M, Inc
Category: Medical Device — Orthopedic Instrument
Hazard: structural-defect
breakage

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 # FKXJ

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 →

Same manufacturer · K2M, Inc

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