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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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Product Detail

Product Description DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.
Recall Number Z-0705-2013
Classification Class II
Code Info All lots
Product Distributed Qty 34 units
Reason For Recall Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPERĀ® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Event Detail

Event Id 63665
Product Type Devices
Status Ongoing
Recalling Firm DePuy Spine, Inc.
City Raynham
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.