• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Synthes

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
 Class 2 Device Recall DePuy Synthes see related information
Date Posted January 24, 2013
Recall Status1 Terminated on December 24, 2013
Recall Number Z-0711-2013
Recall Event ID 63665
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl
Product Code: 1867-15-170

Spinal Implant Component.
Code Information All lots
Recalling Firm/
DePuy Spine, Inc.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information Contact
Manufacturer 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
FDA Determined
Cause 2
Component change control
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.