K2M Aleutian Spreader May Break During Spine Surgery

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Recalling firmK2M, Inc600 Hope Pkwy SE, N/A · Leesburg, VA 20175-4428

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✎ GovInfoNow plain-language explainer

What happened, in plain English

K2M is recalling a type of spinal spacer used in surgery because it can break during procedures, potentially causing complications. This affects specific models with catalog number 5203-90115 and lot number FKXA.

Why it’s dangerous

The spacer is made of two welded pieces that can break during surgery, causing the tip to detach. This may lead to complications if the broken piece remains in the patient or causes injury during the procedure.

Who’s affected

Surgical patients and medical professionals using K2M's Aleutian Anatomically Narrow Lordotic Spreader systems for spinal procedures. Those with the specific catalog number 5203-90115 and lot number FKXA are most at risk.

How to tell if you have this one

Check for the catalog number 5203-90115 and lot number FKXA on the product label. This spacer is used in spinal procedures to simulate cage height and expand disc space.

Brand
K2M
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for catalog number 5203-90115 and lot number FKXA on the spacer's label.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states the spacer can break during procedures, so it is not safe to use without checking the recall status.

What should I do if I have this product?

The recall does not specify a remedy, so check with K2M directly for guidance.

How can I tell if I have the recalled product?

Look for catalog number 5203-90115 and lot number FKXA on the product label.

Take action

Contact K2M

We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2012-2020 — K2M K2M

Hello,

I own a K2M that is covered by recall Z-2012-2020 from K2M.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2012-2020 (April 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2012-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

K2M, Inc recalls K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog #

Use caution until it’s fixed