K2M Aleutian Spreader Risk: Tip Breakage During Spine Procedure

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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 certain spine spacers because the device can break off during surgery, potentially causing complications. This affects surgeons and hospitals using the specific model with catalog number 5203-90177.

Why it’s dangerous

The spacer is made of two welded pieces that can break off during surgery. This breakage could lead to complications if the broken piece remains in the patient's body or causes other issues during the procedure.

Who’s affected

Surgeons and hospitals using the Aleutian Anatomically Narrow Lordotic Spreader with catalog number 5203-90177 are affected. The risk is highest for medical professionals during spinal procedures.

How to tell if you have this one

Check for catalog number 5203-90177 and lot number FKXV on the device. The product is a stainless steel, non-sterile spacer used for spine 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 5203-90177 and lot number FKXV on the spacer.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates a risk of tip breakage during procedures, so it should not be used until the remedy is applied.

What should I do if I have this product?

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

How can I tell if I have the recalled product?

Check for catalog number 5203-90177 and lot number FKXV 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-2029-2020 — K2M K2M

Hello,

I own a K2M that is covered by recall Z-2029-2020 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-2029-2020 (April 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2029-2020 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