Recall Z-1695-2021— K2M, Inc

Name: FDA recall Z-1695-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-07

Class II · Terminated

Class II FDA medical device recall by K2M, Inc, initiated 2021-05-07, terminated 2023-03-08. It names 2 FDA 510(k) clearances: K172009, K150481. 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 fusion in patients with degenerative disc disease.. Reason: Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm.

Recalling firm: K2M, Inc
Classification: Class II
Status: Terminated
Initiated: 2021-05-07
Terminated: 2023-03-08
Firm location: Leesburg, VA, United States

510(k) clearances named in this recall

2 on FDA's record

K172009 — Cascadia Interbody SystemK2m, Inc.·cleared 2017-12-14
K150481 — Cascadia Interbody SystemK2m, Inc.·cleared 2015-08-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.