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 plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.
FDA Recall Z-2273-2012 · Posted 2012-08-27
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Recalling FirmAlphatec Spine, Inc.
Recall StatusTerminated
Product CodeKWQ
Date Initiated2012-05-29
Date Terminated2012-09-04
Product Quantity38
Reason for Recall
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.
Firm 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 [email protected] questions regarding this recall.)
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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