The Recall Desk

FDA (Devices) recall action 85982

Wright Medical Technology, Inc. recalled 2 products on 2020-08-19

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
2020-08-19
Critical
0
Units
75

Why these products were recalled

Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.

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)··2020-08-19

    Wright Medical Hardware Removal Kit Recalled for Missing Drivers

    Wright Medical Technology is recalling 66 hardware removal kits because they lack the specific drivers needed to remove Dart-Fire 2.5 and 3.0mm Headless screws.

    Product
    Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a ra
    Category
    Distribution
    14 states
  • ModerateFDA (Devices)··2020-08-19

    Wright Medical Screw Removal Case Assembly Recalled for Missing Drivers

    Wright Medical Technology is recalling 9 units of the Screw Removal Case Assembly because the kits do not include drivers required to remove specific headless screws.

    Product
    Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles a
    Category
    Distribution
    14 states