The Recall Desk

FDA (Devices) recall action 66298

SpineFrontier, Inc. recalled 3 products on 2014-01-22

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
2014-01-22
Critical
0
Units
69

Why these products were recalled

Handles and heads may not be compatible.

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)··2014-01-22

    SpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L trial heads because they may not be compatible with the trial handles.

    Product
    Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2014-01-22

    SpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L 35x26 Trial Heads because they may not be compatible with the trial handles.

    Product
    Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2014-01-22

    SpineFrontier Recalls Arena-L Trial Handles and Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L Trial Handles and Heads because the components may not be compatible. The devices were distributed only to the U.S. Department of Veterans Affairs.

    Product
    Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are…
    Category
    Distribution
    1 state