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Recall

Class II — DePuy Spine, Inc.

Recalling firmDePuy Spine, Inc.
Registered facilityDEPUY SPINE, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonPolyaxial 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
ProductDePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component.
Quantity2 units
DistributionWorldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.
Initiated2012-11-07
Classified2013-01-23
Terminated2013-12-24
Recall numberZ-0711-2013
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — DePuy Spine, Inc. (Z-0711-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63665/

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