The Recall Desk

FDA (Devices) recall action 66873

SpineFrontier, Inc. recalled 3 products on 2014-01-01

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
2014-01-01
Critical
0
Units
42

Why these products were recalled

Screw inserters may not mate properly with hex interface of the 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

1–3 of 3

  • ModerateFDA (Devices)··2014-01-01

    SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect

    SpineFrontier is recalling four PedFuse Screw Inserters because they may not mate properly with the hex interface of the screws.

    Product
    PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
    Category
    Distribution
    7 states
  • ModerateFDA (Devices)··2014-01-01

    SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect

    SpineFrontier, Inc. is recalling 13 PedFuse Reset Screw Inserters because they may not mate properly with the hex interface of the screws.

    Product
    PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
    Category
    Distribution
    7 states
  • ModerateFDA (Devices)··2014-01-01

    SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect

    SpineFrontier, Inc. is recalling 25 PedFuse Screw Inserters because they may not mate properly with the hex interface of the screws.

    Product
    PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
    Category
    Distribution
    7 states