The Recall Desk
ModerateFDA (Devices)·Z-1695-2021·Announced 2021-06-09

K2M Cascadia AN Interbody Implants Recalled for Mislabeled Dimensions

K2M, Inc is recalling Cascadia AN Interbody Convex lumbar implants with mislabeled product dimensions. The affected sizes include 10x22x14mm, 10x28x14mm, and 10x22x15mm. No injuries have been reported.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This FDA Class II recall involves mislabeled product dimensions with no reported illnesses or injuries. The hazard is a documentation or labeling issue, which is classified as a minor labeling error with theoretical risk, consistent with a Moderate severity rating.

Plain-English summary

K2M, Inc is recalling specific lots of Cascadia AN Interbody Convex lumbar implants (Catalog Number 6101-2102214NC-G2, Lot Number NCMR-4437922) due to mislabeled product labeling. The product labeling references incorrect length or height dimensions for the affected sizes: 10x22x14mm, 10x28x14mm, and 10x22x15mm. These are intervertebral body fusion devices indicated for use with bone graft as an adjunct to spinal fusion in patients with degenerative disc disease.

The recall affects 3 units that were distributed worldwide, including the United States (Massachusetts, Michigan, New Jersey, Pennsylvania, and Utah) and internationally (Italy and Netherlands). The affected product has an expiration date of December 10, 2025.

Patients who have received this implant should contact their healthcare provider to discuss their specific implant and confirm the correct dimensions. Healthcare facilities that may have inventory of the affected product should also contact K2M, Inc. No illnesses or injuries have been reported in association with this recall.

The FDA classified this as a Class II recall.

The recalled product

Product
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
Manufacturer
K2M, Inc
Category
Medical Device — Spinal Fusion Implants
Hazard
  • mislabeling

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: NCMR-4437922 Expiration Date 12-10-2025

Distribution

Distributed nationwide across the United States.

Related recalls

Same category