Devices

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
1 Event
- Recall of Device Recall Quintex Cervical Plating System Screws

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

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