Z-1455-2012

Quintex Cervical Plating System - Screws. The Quintex Cervical Plating System is intended for the treatment...

Name: Z-1455-2012 Quintex Cervical Plating System - Screws. The Quintex Cervical Plating System is intended for the treatment...
Creator: Aesculap Implant Systems
Published: 2012-01-24
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2012-01-24 / Terminated / root cause: manufacturing process

FDA source

Aesculap Implant Systems began a recall of Quintex Cervical Plating System - Screws. The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability. The Quintex... on 2012-01-24. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1455-2012
Status: Terminated
Initiated: 2012-01-24
Posted: 2012-04-25
Terminated: 2012-12-13
Recalling firm: Aesculap Inc
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.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 891
Distribution: Nationwide Distribution, including the states of CA, CO, FL, MO, and TX.
Product codes and lots: 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 code KWQ

K100243Class IIQuintex Cervical Plating SystemAesculap Implant Systems, LLC / cleared 2010-09-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)