Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. 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.
FDA Recall Z-1937-2012 · Posted 2012-07-03
Recalling FirmDePuy Mitek, Inc., a Johnson & Johnson Co.
Recall StatusTerminated
Product CodeOAR
Date Initiated2012-05-04
Date Terminated2016-08-04
Product Quantity683 units
Reason for Recall
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Firm Action
Depuy 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 .
Root Cause
Labeling design
Distribution Pattern
Worldwide 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.