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Recall Observatory FDA recall evidence

Device product

DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.

Z-0707-2013

November 07, 2012

Class II

Product summary

Firm
DePuy Spine, Inc.
Event
Event 63665
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0707-2013

Official wording

Reason: 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

Code information: All lots

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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