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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy Spine Side Fire Needles

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 Class 2 Device Recall Depuy Spine Side Fire Needlessee related information
Date Initiated by FirmMay 04, 2012
Date PostedJuly 03, 2012
Recall Status1 Terminated 3 on August 04, 2016
Recall NumberZ-1938-2012
Recall Event ID 61874
Product Classification Injector, vertebroplasty (does not contain cement) - Product Code OAR
ProductDepuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Code Information All lots
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767
For Additional Information Contact
800-255-2500
Manufacturer Reason
for Recall		Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
FDA Determined
Cause 2		Labeling design
ActionDepuy Spine sent a "CORRECTION NOTICE" to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Correction Notification Form was attached for customers to complete and return via fax to 508-828-3070. For questions about Confidence Needles, please contact your local DePuy Spine Sales Representative. If you need assistance in locating your local Sales Representative please contact JJHCS CIS @ 1 -800-255 -2500 .
Quantity in Commerce704 units
DistributionWorldwide Distribution-USA (nationwide) and the countries of Canada, Austria, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, New Zealand, Poland, Russian Federation, Singapore, South Africa, Spain, Switzerland, Turkey, UAE, 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.
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