Events

Recall of Device Recall Quintex Cervical Plating System Screws

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aesculap Implant Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61346
  • Event Risk Class
    Class 2
  • Event Number
    Z-1455-2012
  • Event Initiated Date
    2012-01-24
  • Event Date Posted
    2012-04-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107844
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Reason
    The firm has received complaints that the locking ring that sits in the head of the screw can come out of the screw head when engaged with the screwdriver if the screwdriver is improperly angled.
  • Action
    The firm initiated this recall by sending an "Important Recall Notification" letter to consignees on January 20, 2012. This letter instructed consignees not to use the product and requested that all stock be returned to the recalling firm promptly. Customers may contact 1-(866) 229-3002 for questions.

Device

Device Recall Quintex Cervical Plating System Screws
  • Model / Serial
    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.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution, including the states of CA, CO, FL, MO, and TX.
  • Product Description
    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
    Aesculap Implant Systems

Manufacturer

Aesculap Implant Systems
  • Manufacturer Address
    Aesculap Implant Systems, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA