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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 Device Recall Zodiac Pedicle Screw System see related information
Date Initiated by Firm December 09, 2010
Date Posted November 08, 2012
Recall Status1 Terminated 3 on November 09, 2012
Recall Number Z-0269-2013
Recall Event ID 63599
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 CA 92008-8816
For Additional Information Contact
760-431-9286
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		 Error in labeling
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 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 MFG., INC.
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