Recall Z-0963-2013 ยท NDN Cement, Bone, Vertebroplasty
DePuy Spine, Inc.
DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
| Date | Mar 18, 2013 (initiated Jan 15, 2013) |
| Status | Terminated |
| Reason | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck |
| Root cause | Process control |
| Action | DePuy Synthes Spine issued notification letter dated 1/11/13 issued via UPS Next Day Air Saver on 17 January 2013. Accounts requested to review inventory, quarantine any products listed in this recall notice and to complete and return the enclosed Business Reply Form. Contact the firm at 508-977-6606 for questions relating to this notice. |
| Quantity | 6668 |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, Ind |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060300 | CONFIDENCE HIGH VISCOSITY BONE CEMENT Disc-O-Tech Medical Technologies, Ltd., Jun 21, 2006 |