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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Synthes

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 Class 2 Recall
DePuy Synthes
see related information
Date Posted January 24, 2013
Recall Status1 Terminated on December 24, 2013
Recall Number Z-0709-2013
Recall Event ID 63665
Premarket Notification
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 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.
Code Information All lots
Recalling Firm/
Manufacturer
DePuy Spine, Inc.
325 Paramount Dr
Raynham, Massachusetts 02767-5199
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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 34 uits
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.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = DEPUY SPINE, INC.
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