| Class 2 Device Recall CONFIDENCE SPINAL CEMENT SYSTEM KIT | |
Date Initiated by Firm | January 15, 2013 |
Date Posted | March 18, 2013 |
Recall Status1 |
Terminated 3 on June 30, 2014 |
Recall Number | Z-0963-2013 |
Recall Event ID |
64072 |
510(K)Number | K060300 |
Product Classification |
Cement, bone, vertebroplasty - Product Code NDN
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Product | DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT
Catalog Number: 283913000.
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
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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 | 6668 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = NDN
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