K2M Cascadia lumbar implants recalled for mislabeled dimensions
K2M, Inc. is recalling Cascadia AN Interbody Convex lumbar implants due to incorrect dimensions listed on product labels for specific lot numbers and device sizes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving mislabeled dimensions on surgical implants. No illnesses or injuries have been reported, but incorrect dimensions on a lumbar implant constitute a risk-of-harm product where the hazard remains theoretical.
Plain-English summary
K2M, Inc. is recalling Cascadia AN Interbody Convex lumbar implants (Catalog Number 6101-2102814NC-G2) due to product labeling that references incorrect length or height dimensions. The mislabeling affects specific device sizes, including 10x22x14mm, 10x28x14mm, and 10x22x15mm models.
Lumbar implants are intervertebral body fusion devices used with bone graft as an adjunct to spinal fusion surgery in patients with degenerative disc disease. Incorrect dimension labeling could result in selection of an inappropriately sized implant during surgical placement.
The recall affects 3 units of lot number NCNE-4437924 (expiration date December 10, 2025). In the United States, affected devices were distributed to Massachusetts, Michigan, New Jersey, Pennsylvania, and Utah. The product was also distributed to Italy and the Netherlands.
The recalled product
- Product
- 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…
- Manufacturer
- K2M, Inc
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: NCNE-4437924 Expiration Date 12-10-2025
Distribution
Part of a larger recall action
This product is one of 3 recalled by K2M, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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