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 that have incorrect size labels. This could lead to improper surgical fitting if used without proper verification of the correct dimensions.

Why it’s dangerous

The implants have mislabeled dimensions (length or height) that could cause improper surgical fit. This might lead to complications during spinal fusion procedures if the wrong size is used.

Who’s affected

Patients who received these specific lumbar implants for spinal fusion surgery are affected. Surgeons and medical staff using the implants during procedures are most at risk.

How to tell if you have this one

Check for catalog number 610:2102215NC-G2 and lot number NCMT-4437923 on the implant packaging. These specific sizes (10x22x14mm, 10x28x14mm, 10x22x15mm) are affected.

Brand
K2M
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Verify Product Label
Check the implant's catalog number and lot number to confirm if it matches the recalled items (6101-2102215NC-G2 and NCMT-4437923).

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The implants have mislabeled dimensions that could lead to improper surgical fit during spinal fusion procedures.

What specific sizes are affected?

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

How can I check if my implant is recalled?

Look for catalog number 6101-2102215NC-G2 and lot number NCMT-4437923 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-1696-2021 — K2M K2M

Hello,

I own a K2M that is covered by recall Z-1696-2021 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-1696-2021 (May 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1696-2021 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 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body

Lower-risk recall