Recall Z-1937-2012 ยท OAR Injector, Vertebroplasty (Does Not Contain Cement)
DePuy Mitek, Inc., a Johnson & Johnson Co.
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.
| Date | Jul 3, 2012 (initiated May 4, 2012) |
| Status | Terminated |
| Reason | Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles |
| Root cause | Labeling design |
| 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 . |
| Quantity | 683 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.