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.
FDA Recall Z-1455-2012 · Posted 2012-04-25
Recalling FirmAesculap Implant Systems
Recall StatusTerminated
Product CodeKWQ
Date Initiated2012-01-24
Date Terminated2012-12-13
Product Quantity891
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution, including the states of CA, CO, FL, MO, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.