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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 KIT see related information
Date Initiated by Firm January 15, 2013
Date Posted March 18, 2013
Recall Status1 Terminated 3 on June 30, 2014
Recall Number Z-0961-2013
Recall Event ID 64072
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 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
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 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 = NDN and Original Applicant = DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
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