The Recall Desk

FDA (Devices) recall action 87905

K2M, Inc recalled 3 products on 2021-06-09

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2021-06-09
Critical
0
Units
13

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2021-06-09

    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.

    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 t
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2021-06-09

    K2M Cascadia AN Interbody Lumbar Implants recalled for mislabeled dimensions

    K2M, Inc is recalling Cascadia AN Interbody Convex lumbar implants (Lot NCMT-4437923) due to product labeling that references incorrect length or height dimensions. Seven units were distributed to the US and internationally.

    Product
    Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-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 t
    Category
    Distribution
    5 states
  • ModerateFDA (Devices)··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.

    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
    Category
    Distribution
    5 states