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.
Recall
- Recall Number
- Z-1455-2012
- Event Number
- 61346
- Firm
- Aesculap Implant Systems
- FEI Number
- 2916714
- Product Code
- KWQ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- January 24, 2012
- Posted
- April 25, 2012
- Terminated
- December 13, 2012
- Address
- 3773 Corporate Pkwy, Center Valley, PA, 18034-8217
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.
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.
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.
Nationwide Distribution, including the states of CA, CO, FL, MO, and TX.
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