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.
Hazard
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
What You Should Do
Remedy
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 .
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Products
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 fashio
- Brand
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- UPC
- All lots
Units Affected
683 units