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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 Device Recall CONFIDENCE SPINAL CEMENT SYSTEM 7CC KITsee related information
Date Initiated by FirmJanuary 15, 2013
Date PostedMarch 18, 2013
Recall Status1 Terminated 3 on June 30, 2014
Recall NumberZ-0961-2013
Recall Event ID 64072
510(K)NumberK060300 
Product Classification Cement, bone, vertebroplasty - Product Code NDN
ProductDePuy 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 MA 02767-5199
For Additional Information Contact
508-828-3769
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		Process control
ActionDePuy 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 Commerce549
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = NDN
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