DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component.

FDA device recall Z-0711-2013 · posted 2013-01-24 · Terminated

Recall details

Recalling firm

DePuy Spine, Inc.

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

Action taken

DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.

Root cause

Component change control

Status

Terminated

Product code

NKB

Quantity affected

2 units

Distribution

Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.

Date initiated

2012-11-07

Date posted

2013-01-24

Date terminated

2013-12-24

Location

Raynham, MA