Device Recall Orthofix

  • Model / Serial
    Production Identification Numbers: Part Number 52-1332, All Lot Numbers.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.
  • Product Description
    Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, || Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Orthofix, Inc., 3451 Plano Pkwy, Lewisville TX 75056-9453
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    UDI 18257200125371, Lot Numbers: O02, O03 and O04
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    Yes
  • Distribution
    US
  • Product Description
    ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
  • Manufacturer
  • Model / Serial
    UDI 18257200125364, Lot Numbers: O01 and O02
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    Yes
  • Distribution
    US
  • Product Description
    ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
  • Manufacturer