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U.S. Department of Health and Human Services

Class 2 Device Recall Solanas

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  Class 2 Device Recall Solanas see related information
Date Initiated by Firm August 05, 2009
Date Posted December 14, 2009
Recall Status1 Terminated 3 on June 07, 2010
Recall Number Z-0503-2010
Recall Event ID 53144
510(K)Number K052201  K071380  
Product Classification Pedicle Screw - Product Code KWP
Product Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14
Code Information Lot Numbers: 624241, 624242, 625418
Recalling Firm/
Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad CA 92008-8816
For Additional Information Contact
Manufacturer Reason
for Recall
Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.
FDA Determined
Cause 2
Process control
Action Alphatec Spine telephoned consignees informing them of the above mentioned Public Reason for Recall on August 5, 2009. They were asked to check their inventory to see where this product is located. If the product had not already been used Alphatec arranged to have Federal Express contact consignee for pick-up of the product(s). They were told to expect to receive the replacement(s) within 2-3 days.
Quantity in Commerce 158 units
Distribution Nationwide distribution.
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.