DePuy Spine, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0713-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 7, 2012

Date Posted: January 30, 2013

Recall Number: Z-0713-2013

Event ID: 63665

Reason for Recall:

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.

Status: Terminated

Product Quantity: 10 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated