Recall Z-2273-2012 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Alphatec Spine, Inc.
TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid p
| Date | Aug 27, 2012 (initiated May 29, 2012) |
| Status | Terminated |
| Reason | On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721), does not properly fit into the hexalobe screw on the Trestle Luxe Plate. |
| Root cause | Device Design |
| Action | Alphatec Spine sent an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" letter dated May 29, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A form was attached for customers to complete and return via fax to 760-431-0289. Contact Alphatec Spine's Customer Service Department at customerservice@alphatecspine.comfor questions regarding this recall.) |
| Quantity | 38 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102820 | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Alphatec Spine, Inc., Nov 5, 2010 |