K2M Aleutian Interbody Spacer Systems Recall: Spreader Tip Breakage Risk

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

K2M is recalling Aleutian Interbody Spacer Systems because the spreader tip can break off during spinal procedures. This poses a risk of injury to patients during surgery.

Why it’s dangerous

The spreader tip can break off during spinal procedures, potentially causing injury to the patient. This occurs because the device is manufactured as two pieces welded together.

Who’s affected

Patients undergoing spinal surgery who use the recalled Aleutian Interbody Spacer Systems are at risk. Medical professionals using the device for procedure simulation are also affected.

How to tell if you have this one

Check for catalog number 5203-90169 and lot number FKXU on the device. The device is a stainless steel, non-sterile interbody spacer system used for spinal procedures.

Brand
K2M
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Look for catalog number 5203-90169 and lot number FKXU on the device.

✎ GovInfoNow

Questions people ask

Is this device used in surgery?

Yes, the device is used to simulate spine cage height and expand disc space during spinal procedures.

What is the risk of using this device?

The spreader tip can break off during procedures, potentially causing injury to the patient.

How can I tell if I have the recalled device?

Check for catalog number 5203-90169 and lot number FKXU on the device.

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-2028-2020 — K2M K2M

Hello,

I own a K2M that is covered by recall Z-2028-2020 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-2028-2020 (April 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2028-2020 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