The Recall Desk

FDA (Devices) recall action 76104

In2Bones, SAS recalled 3 products on 2017-01-18

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
2017-01-18
Critical
0
Units
85

Why these products were recalled

Dimensional non-conformity of the thread on the screw head.

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.

1–3 of 3

  • HighFDA (Devices)··2017-01-18

    In2Bones Recalls NEOVIEW Locking Screws Due to Thread Dimensional Non-Conformity

    In2Bones is recalling 40 units of NEOVIEW locking screws due to dimensional non-conformity of the thread on the screw head. The recall covers units distributed in the US, France, and Switzerland.

    Product
    NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-01-18

    In2Bones Recalls 19 Locking Screws Due to Thread Dimensional Non-Conformity

    In2Bones is recalling 19 locking screws from the NEOVIEW Plating System due to dimensional non-conformity of the thread on the screw head.

    Product
    SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-01-18

    In2Bones Recalls NEOVIEW Screws Due to Thread Dimensional Non-Conformity

    In2Bones is recalling 26 units of NEOVIEW Screws Set due to dimensional non-conformity of the thread on the screw head.

    Product
    NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
    Category
    Distribution
    0 states