Skip to content
Recall Observatory FDA recall evidence

Device product

DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.

Z-0713-2013

November 07, 2012

Class II

Product summary

Firm
DePuy Spine, Inc.
Event
Event 63665
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-0713-2013

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.