K2M, Inc: Medical Device Recall in 2021 - (Recall #: Z-1695-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 7, 2021

Date Posted: June 9, 2021

Recall Number: Z-1695-2021

Event ID: 87905

Reason for Recall:

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

Status: Terminated

Product Quantity: 3 units

Code Information:

Lot Number: NCMR-4437922 Expiration Date 12-10-2025

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated