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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Product Detail

Product Description 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.
Recall Number Z-0269-2013
Classification Class II
Code Info Lot # 634745
Product Distributed Qty 11 units
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.

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 Telephone
Distribution Pattern Nationwide Distribution including TN, WI, and FL.