Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. 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.
Recall
- Recall Number
- Z-1940-2012
- Event Number
- 61874
- Firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- FEI Number
- 1221934
- Product Code
- OAR
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- May 4, 2012
- Posted
- July 3, 2012
- Terminated
- August 4, 2016
- Address
- 325 Paramount Dr, Raynham, MA, 02767
Description
Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. 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.
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
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 .
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.
6979 units