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U.S. Department of Health and Human Services

Class 2 Device Recall Solanas Posterior Stabilization System

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  Class 2 Device Recall Solanas Posterior Stabilization System see related information
Date Initiated by Firm November 01, 2010
Date Posted January 31, 2012
Recall Status1 Terminated 3 on January 31, 2012
Recall Number Z-0932-2012
Recall Event ID 59920
510(K)Number K052201  K071380  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
Product Solanas Posterior Stabilization System Part Number: 63920.

Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Solanas Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
Code Information Lot Numbers: 608227B, 609867B, 609870B, 609882B, 609897B, 609971B
Recalling Firm/
Manufacturer
Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad CA 92008-8816
For Additional Information Contact
760-431-9286
Manufacturer Reason
for Recall
These lots were not manufactured correctly in that the instrument does not have the durability required to repeatedly perform over its full service life and, therefore, may experience breakage in the tips.
FDA Determined
Cause 2
Device Design
Action Alphatec Spine contacted all affected customers via telephone. The communication included discussion of the product, problem, and actions to be taken by the customers. Customers were instructed to remove the affected product from inventory and to return the product to the firm. Arrangements were made for replacement product to be sent to the customers. Contact the firm at 1-800-922-1356 for questions regarding this recall.
Quantity in Commerce 27 units
Distribution Nationwide Distribution-including the states of CA, CT, FL, GA, NC, NE, NJ, TX, and UT.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = ALPHATEC SPINE, INC.
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