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U.S. Department of Health and Human Services

Class 2 Device Recall CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT

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 Class 2 Recall
CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT
see related information
Date Posted March 18, 2013
Recall Status1 Open
Recall Number Z-0961-2013
Recall Event ID 64072
Premarket Notification
510(K) Number
K060300 
Product Classification Cement, Bone, Vertebroplasty - Product Code NDN
Product DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
Code Information All lots
Recalling Firm/
Manufacturer
DePuy Spine, Inc.
325 Paramount Dr
Raynham, Massachusetts 02767-5199
Manufacturer Reason
for Recall
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action DePuy Synthes Spine issued notification letter dated 1/11/13 issued via UPS Next Day Air Saver on 17 January 2013. Accounts requested to review inventory, quarantine any products listed in this recall notice and to complete and return the enclosed Business Reply Form. Contact the firm at 508-977-6606 for questions relating to this notice.
Quantity in Commerce 549
Distribution Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.
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 = NDN and Original Applicant = DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
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