The Recall Desk
SevereFDA (Devices)·Z-2010-2020·Announced 2020-05-27

K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

K2M, Inc. is recalling the Aleutian Anatomically Narrow 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 involves a structural defect in a medical device used during spinal surgery where the tip breaks off, posing a significant risk of injury to the patient, which aligns with the rubric for significant injury reports or structural defects.

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 the procedure.

The affected product is identified by Lot # FKWX, Catalog # 5203-90111, and UDI # 10888857108240. The device is available in a 24x8mm size. 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 lots immediately and contact K2M, Inc. for instructions on return or replacement. Patients who have had this device used during a procedure 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 # 5203-90111, UDI # 10888857108240, Size 24x8mm, 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 — Spinal Instrumentation
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 # FKWX

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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