CLASS II Device recall · Reported 9 Jun 2021 · FDA Enforcement Report

Cascadia AN Interbody Convex 10x28x14mm recalled by K2M

K2M is recalling Cascadia AN Interbody Convex 10x28x14mm, distributed nationwide in the US. The recall was initiated on 7 May 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: NCNE-4437924 Expiration Date 12-10-2025

Quantity recalled3 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1697-2021
FDA event ID: 87905
Recalling firm: K2M, Leesburg, VA
Classification: Class II
Status: Terminated
Recall initiated: 7 May 2021
FDA classified: 1 Jun 2021
Reported: 9 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Labeling Errors
Device type: Spinal Implants

Timeline

7 May 2021	Recall initiated by company
1 Jun 2021	Classified by FDA	+25 days
9 Jun 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of MA, MI, NJ, PA, UT and the countries of Italy, Netherlands.

Nationwide Massachusetts Michigan New Jersey Pennsylvania Utah

Questions about this recall

Is Cascadia AN Interbody Convex 10x28x14mm recalled?

Yes. K2M recalled Cascadia AN Interbody Convex 10x28x14mm on 7 May 2021. The recall is Class II and its status is Terminated. Recall number Z-1697-2021.

Why was it recalled?

Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm

Which lots are affected?

Lot Number: NCNE-4437924 Expiration Date 12-10-2025

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of MA, MI, NJ, PA, UT and the countries of Italy, Netherlands.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from K2M

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6 Jul 2022Device	CLASS II	Yukon Straight Rod recalled by K2M	K2M	Other	6 states
9 Mar 2022Device	CLASS II	Everest MI XT Outer Dilator recalled by K2M	K2M	Other	Nationwide
9 Mar 2022Device	CLASS II	Everest MI XT Inner Dilator recalled by K2M	K2M	Other	Nationwide
20 Oct 2021Device	CLASS II	Chesapeake Anterior Lumbar (AL) Removal Tool recalled by K2M	K2M	Other	9 states
9 Jun 2021Device	CLASS II	Cascadia AN Interbody Convex 10x22x14mm recalled by K2M	K2M	Labeling Errors	Nationwide

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