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U.S. Department of Health and Human Services

Class 2 Device Recall Zodiac Pedicle Screw System

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 Class 2 Recall
Zodiac Pedicle Screw System
see related information
Date Posted November 08, 2012
Recall Status1 Terminated on November 09, 2012
Recall Number Z-0269-2013
Recall Event ID 63599
Premarket Notification
510(K) Number
K033090 
Product Classification Appliance, Fixation, Spinal Interlaminal - Product Code KWP
Product TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
Code Information Lot # 634745
Recalling Firm/
Manufacturer
Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, California 92008-8816
Manufacturer Reason
for Recall
The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.
FDA Determined
Cause 2
TRAINING: Employee Error
Action Alphatec Spine distributors who received the TI Standard Polyaxial Screw Assembly were contacted by phone and by email on December 9, 2010. A phone script was used as a recall notification to contact their three distributors who received the recalled products. The recall notification informed the customers of the problem identified and the action to be taken. Customers were informed that they will receive replacements within 2-3 days. Customers with questions were instructed to call (800) 922-1356. For questions regarding this recall call 760-431-9286.
Quantity in Commerce 11 units
Distribution Nationwide Distribution including TN, WI, and FL.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = ALPHATEC MFG., INC.
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