Device Recall NEO(R) NonLocking screws

  • Model / Serial
    All batch numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Diribution - US including Tennessee; Foreign - Italy, Portugal, Spain, Switzerland, UK, and France
  • Product Description
    Non-Locking screws in the following lengths: || (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 || (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 || (c) DRP 0.27 - 12 mm, REF W27 ST012 || (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 || (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 || (f) NEO(R) 0.27 - 18 mm, REF W27 ST018 || (f) DRP 0.27 - 18 mm, REF W27 ST018 || The NEOVIEW(R) Plating System is intended for fixation of intra-articular and extra-articular fractures of the distal radius and reconstruction of the distal radius. It is composed of a NEOVIEW" plate in PEEK and NE0411 screws in Ti6Al4V that are available in Locking or Non-Locking versions. The NEOVIEW411 Screw Set consists of a standard set of NE0411 screws with different lengths suitable for the implantation of a NEOVIEW9 plate for an average anatomy
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    In2Bones, SAS, 28 Chemin du petit Bois, Ecully France
  • Manufacturer Parent Company (2017)
  • Source
    USFDA