The Recall Desk

FDA (Devices) recall action 66914

SpineFrontier, Inc. recalled 4 products on 2014-01-01

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2014-01-01
Critical
0
Units
1,915

Why these products were recalled

Mismarked and unmarked 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

1–4 of 4

  • ModerateFDA (Devices)··2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling Indus Invue Screws due to mismarked and unmarked units. The recall covers nationwide distribution.

    Product
    Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Distribution
    10 states
  • ModerateFDA (Devices)··2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling Indus Invue Screws due to mismarked and unmarked units. These screws are used to secure anterior cervical plates.

    Product
    Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Distribution
    10 states
  • ModerateFDA (Devices)··2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling 993 Indus Invue screws used in cervical spine surgery because they are mismarked or unmarked.

    Product
    Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Distribution
    10 states
  • ModerateFDA (Devices)··2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling 922 Indus Invue Screws because they are mismarked or unmarked. These screws are used to secure anterior cervical plates.

    Product
    Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Distribution
    10 states