K2M Cascadia AN Interbody Convex Implants: Mislabeled Size Risk

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

K2M is recalling certain lumbar spinal implants because their size labels are incorrect. This could lead to improper surgical use if the wrong size is installed, potentially causing complications during spinal fusion procedures.

Why it’s dangerous

The implants have incorrect size labels (10x22x14mm, 10x28x14mm, 10x22x15mm) that could lead to improper surgical use. If the wrong size is installed during spinal fusion, it might not fit correctly, causing potential complications.

Who’s affected

Surgical patients who received these specific lumbar implants during procedures between 2020 and 2025 are affected. Surgeons and medical facilities using these implants are most at risk of complications.

How to tell if you have this one

Check for catalog number 6101-2102214NC-G2 and lot number NCMR-4437922 on the implant packaging. These specific sizes (10x22x14mm, 10x28x14mm, 10x22x15mm) were affected by mislabeling.

Brand
K2M
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for catalog number 6101-2102214NC-G2 and lot number NCMR-4437922 on the implant packaging.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The implants have incorrect size labels that could lead to improper surgical use if the wrong size is installed during spinal fusion procedures.

What specific sizes are affected?

The affected sizes are 10x22x14mm, 10x28x14mm, and 10x22x15mm.

How can I tell if I have the recalled product?

Check for catalog number 6101-2102214NC-G2 and lot number NCMR-4437922 on the implant packaging.

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-1695-2021 — K2M K2M

Hello,

I own a K2M that is covered by recall Z-1695-2021 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-1695-2021 (May 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1695-2021 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 Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body

Lower-risk recall