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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
Recall Number Z-1421-2013
Classification Class II
Code Info 83010 85001 85002 83005-30 83005-35 83005-40 83005-45 83005-50 83006-30 83006-35 83006-40 83006-45 83006-50 83006-55 83006-60 83007-30 83007-35 83007-40 83007-45 83007-50 83007-55 83008-30 83008-35 83008-40 83008-45 83008-50 83008-55 83008-80 82001-1 Catalog Numbers: LA-HSS0010 LA-HDOO01 LA-CTOO02 LA-PS0530 LA-PS0535 LA-PS0540 LA-PS0545 LA-PS0550 LA-PS0630 LA-PS0635 LA-PS0640 LA-PS0645 LA-PS0650 LA-PS0655 LA-PS0660 LA-PS0730 LA-PS0735 LA-PS0740 LA-PS0745 LA-PS0750 LA-PS0755 LA-PS0830 LA-PS0835 LA-PS0840 LA-PS0845 LA-PS0850 LA-PS0855 LA-PS0880 LA-SOO01 Lots Affected: All
Product Distributed Qty 1,814
Reason For Recall Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adverse events or complaints received for this issue.

Event Detail

Event Id 65165
Product Type Devices
Status Ongoing
Recalling Firm Alphatec Spine, Inc.
City Carlsbad
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-06
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide Distribution.