The Recall Desk
SevereFDA (Devices)·Z-2023-2020·Announced 2020-05-27

K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

K2M, Inc. is recalling Aleutian Lordotic Spreader Systems because the welded tips may break off during surgical 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 surgery that can cause the tip to break off, posing a significant risk of injury to the patient.

Plain-English summary

K2M, Inc. is recalling the Aleutian Interbody Spacer Systems, specifically the EN AN Lordotic Spreader (Catalog # 5203-90155, UDI # 10888857108684, Size 28x10mm). The affected product is a stainless steel, non-sterile surgical instrument used to simulate cage height and expand spine disc space to determine optimal implant size.

The recall is due to a manufacturing defect where the spreader, which is constructed from two welded pieces, has been associated with the tip breaking off during the procedure. This presents a risk of injury or procedural failure if the component fails while in use.

The product was distributed worldwide, including nationwide 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 facilities should stop using the affected units 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 # 5203-90155, UDI # 10888857108684, Size 28x10mm, 6 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 # FKXM

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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