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U.S. Department of Health and Human Services

Class 2 Device Recall Quintex Cervical Plating System Screws

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  Class 2 Device Recall Quintex Cervical Plating System Screws see related information
Date Initiated by Firm January 24, 2012
Date Posted April 25, 2012
Recall Status1 Terminated 3 on December 13, 2012
Recall Number Z-1455-2012
Recall Event ID 61346
510(K)Number K100243  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product 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.
Code Information 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.
Recalling Firm/
Aesculap Implant Systems
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Robin M. Fatzinger
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Nonconforming Material/Component
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.
Quantity in Commerce 891
Distribution Nationwide Distribution, including the states of CA, CO, FL, MO, and TX.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWQ and Original Applicant = AESCULAP IMPLANT SYSTEMS, LLC