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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Spine

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  Class 2 Device Recall DePuy Spine see related information
Date Initiated by Firm November 07, 2012
Date Posting Updated January 24, 2013
Recall Status1 Terminated 3 on December 24, 2013
Recall Number Z-0712-2013
Recall Event ID 63665
510(K)Number K101993  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl
Product Code: 1867-15-180

Spinal Implant Component.
Code Information All lots
Recalling Firm/
Manufacturer
DePuy Spine, Inc.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information Contact
508-828-3769
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 6 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = DEPUY SPINE, INC.
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