Recall Z-1455-2012 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Aesculap Implant Systems
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
| Date | Apr 25, 2012 (initiated Jan 24, 2012) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 891 |
| Distribution | Nationwide Distribution, including the states of CA, CO, FL, MO, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100243 | QUINTEX CERVICAL PLATING SYSTEM Aesculap Implant Systems, LLC, Sep 2, 2010 |