RecallRadar

FDA Device recall Z-0713-2013

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

On 2013-01-30 the FDA classified a Class II recall of DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component by Depuy Spine, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0713-2013
ClassificationClass II
Statusterminated
Initiated2012-11-07
Published2013-01-30
Last updated2026-09-13 11:53 UTC
CompanyDepuy Spine
DistributionUS

Product

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

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.

Identifiers

code_infoAll lots

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Other recalls by Depuy Spine

All Depuy Spine recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0713-2013%22

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