The Recall Desk
SevereFDA (Devices)·Z-2015-2020·Announced 2020-05-27

K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

K2M, Inc. is recalling the Aleutian Lordotic Spreader because the welded tip 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 poses a significant risk of 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 recall is due to a manufacturing defect where the device, constructed from two welded pieces, has been associated with the spreader tip breaking off during surgical procedures.

The affected product is identified by Lot # FKXD. Distribution was worldwide, including nationwide distribution in the United States and in Europe. Specific US states mentioned in the distribution pattern include Colorado, Michigan, Texas, California, New York, Florida, Maryland, Oregon, Kansas, Montana, and Missouri.

Healthcare providers and patients should stop using the affected spreader immediately. The device is intended for intraoperative use to determine optimal implant size based on patient anatomy.

The recalled product

Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 10888857108387, Size 24x8mm, 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 — Spinal 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 # FKXD

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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