The Recall Desk

FDA (Devices) recall action 82716

K2M, Inc recalled 2 products on 2019-06-05

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2019-06-05
Critical
0
Units
924

Why these products were recalled

The products are mislabeled.

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

1–2 of 2

  • ModerateFDA (Devices)··2019-06-05

    K2M Fenestrated Tap Adapter Recalled for Mislabeled Packaging

    K2M, Inc. is recalling 462 Fenestrated Tap Adapters because the products are mislabeled. The devices are used for bone biopsies and vertebral body augmentation.

    Product
    Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and…
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2019-06-05

    K2M Fenestrated Taps Recalled for Mislabeled Packaging

    K2M, Inc. is recalling 462 Fenestrated Taps because the products are mislabeled. The devices were distributed to six US states.

    Product
    Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration…
    Category
    Distribution
    6 states