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Recall Observatory FDA recall evidence

Device 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 to fusion in patients with degenerative disc disease.

Z-1697-2021

May 07, 2021

Class II

Product summary

Firm
K2M, Inc
Event
Event 87905
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-1697-2021

Official wording

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

Code information: Lot Number: NCNE-4437924 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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Mislabeled