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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Event Detail

Event ID 63599
Product Type Devices
Status Completed
Recalling Firm Alphatec Spine, Inc.
City Carlsbad
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-12-09
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including TN, WI, and FL.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot # 634745 Class II 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. 11 units Z-0269-2013