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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Event Detail

Event ID 51437
Product Type Devices
Status Completed
Recalling Firm Alphatec Spine, Inc.
City Carlsbad
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-29
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Product code KWQ. 510(k) K102820 Part Number 71721. Lot numbers: 6629701, 6594701, 6434301, 6434302, 6434302R1. Class II 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. 38 Z-2273-2012
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