The Recall Desk

FDA (Devices) recall action 87626

Medtronic Sofamor Danek USA, Inc recalled 2 products on 2021-04-28

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
2021-04-28
Critical
0
Units
22

Why these products were recalled

The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.

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.

1–2 of 2

  • ModerateFDA (Devices)··2021-04-28

    Medtronic Endoskeleton TC Interbody System Recalled for Packaging Labeling Error

    Medtronic is recalling 11 Endoskeleton TC Interbody System devices because shelf boxes were mislabeled, containing the wrong size device.

    Product
    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-04-28

    Medtronic Endoskeleton TC Interbody System Recalled for Incorrect Size Labeling

    Medtronic is recalling 11 Endoskeleton TC Interbody System devices because shelf boxes misidentify the size of the contained device.

    Product
    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone…
    Category
    Distribution
    0 states