Device Recall Quintex Cervical Plating System Screws

  • Modèle / numéro de série
    Semi-constrained -- SC400T - SC406T and SC490T - SC494T; Constrained -- SC500T - SC506T and SC590T - SC594T; Dynamic Screws -- SC600T - SC606T and SC690T - SC694T; all distributed lot numbers and serial numbers. The screws are part of the Quintex Cervical Plating System.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution, including the states of CA, CO, FL, MO, and TX.
  • Description du dispositif
    Quintex Cervical Plating System - Screws. The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability. The Quintex Cervical Screws are available in three different versions: semi-constrained, constrained, and dynamic. The screws all have a head diameter of 4.0mm and vary in length from 10mm to 22mm. Rescue screws are also available with a 4.5mm head diameter and lengths of 11-19mm.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Aesculap Implant Systems, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Société-mère du fabricant (2017)
  • Source
    USFDA