K2M Cascadia AN Interbody Convex Implants: Mislabeled Size Risk
K2M recalls specific lumbar fusion implants due to incorrect size labeling that could lead to improper surgical fit. Affected products have catalog number 6101-210281: 10x22x14mm, 10x28x14mm, 10x22x15mm. Check your lot numbers for recall.
Lower-risk recall
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
Contact the company
What happened, in plain English
K2M is recalling certain lumbar spinal implants because their size labels are incorrect. This could lead to improper surgical fitting if used in procedures. Affected products include specific model sizes with catalog number 6101-2102814NC-G2. Read more at govinfonow.com/recall/62591-k2m-cascadia-an-interbody-convex-implants-mislabeled-size-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62591-k2m-cascadia-an-interbody-convex-implants-mislabeled-size-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1697-2021
Cite this page
“K2M Cascadia AN Interbody Convex Implants: Mislabeled Size Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62591-k2m-cascadia-an-interbody-convex-implants-mislabeled-size-risk. Based on FDA recall #Z-1697-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1697-2021%22&limit=1).
Why it’s dangerous
The implants have incorrect size labels for specific lots and sizes. This could lead to improper surgical fitting if the wrong size is used during spinal fusion procedures. However, the hazard is limited to labeling errors and does not involve immediate safety risks.
Who’s affected
Patients who received these specific lumbar spinal implants for fusion surgery are affected. Surgeons and medical facilities using the recalled models are at risk of improper surgical outcomes.
How to tell if you have this one
Check the product's catalog number: 6101-2102814NC-G2. Look for specific sizes: 10x22x14mm, 10x28x14mm, or 10x22x15mm. The lot number for affected items is NCNE-4437924.
- Brand
K2M- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide distribution - US Nationwide distribution in the states of MA, MI, NJ, PA, UT and the countries of Italy, Netherlands.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1695-2021 | Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.; Lot Number: NCMR-4437922 Expiration Date 12-10-2025 | 3 units |
| Z-1696-2021 | Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.; Lot Number: NCMT-4437923 Expiration Date 12-10-2025 | 7 units |
| Z-1697-2021 | Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.; Lot Number: NCNE-4437924 Expiration Date 12-10-2025 | 3 units |
What to do — step by step
Check Product Label
Look for the catalog number 6101-2102814NC-G2 and specific sizes: 10x22x14mm, 10x28x14mm, or 10x22x15mm.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 5 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of MA, MI, NJ, PA, UT and the countries of Italy, Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Massachusetts, Michigan, New Jersey, Pennsylvania, Utah.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1697-2021 (May 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1697-2021 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.