Quintex Cervical Plating System - Screws. The Quintex Cervical Plating System is intended for the treatment of cervical
FDA device recall Z-1455-2012 · posted 2012-04-25 · Terminated
Recall details
- Recalling firm
- Aesculap Implant Systems
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 891
- Distribution
- Nationwide Distribution, including the states of CA, CO, FL, MO, and TX.
- Date initiated
- 2012-01-24
- Date posted
- 2012-04-25
- Date terminated
- 2012-12-13
- Location
- Center Valley, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUINTEX CERVICAL PLATING SYSTEM (K100243) | Aesculap Implant Systems, LLC | 2010-09-02 |