The Recall Desk
SevereFDA (Devices)·Z-2022-2020·Announced 2020-05-27

K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (tip breakage) in a surgical instrument, which meets the criteria for a Severe rating due to the risk of significant injury during a procedure.

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 specific product affected is the EN AN Lordotic Spreader, Catalog # 5203-90153, UDI # 10888857108660, Size 28x8mm, Lot # FKXL.

The recall is due to a manufacturing defect where the spreader, which is made of two pieces welded together, has been associated with the spreader tip breaking off during the procedure. This defect poses a risk of injury to patients during spinal surgery.

The affected devices were distributed worldwide, including in the United States (specifically in Colorado, Michigan, Texas, California, New York, Florida, Maryland, Oregon, Kansas, Montana, and Missouri) and in Europe. Healthcare providers and facilities should stop using these devices and contact K2M, Inc. for further instructions on return or disposal.

The recalled product

Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 10888857108660, Size 28x8mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implan
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 # FKXL

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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