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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head 10 units Z-0713-2013
DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head 6 units Z-0712-2013
DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component. All lots Class II Polyaxial screws 8x 8 and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head 2 units Z-0711-2013
DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head 23 units Z-0710-2013
DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head 34 uits Z-0709-2013
DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head 24 units Z-0708-2013
DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head Z-0707-2013
DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head 36 units Z-0706-2013
DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component. All lots Class II Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER® large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head 34 units Z-0705-2013
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