Recall Z-1300-2018 ยท NDN Cement, Bone, Vertebroplasty
DePuy Spine, Inc.
Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral
| Date | Dec 15, 2017 |
| Status | Terminated |
| Reason | Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTIFICATION-RECALL CONFIDENCE KIT SPINAL CEMENT SYSTEM" dated 12/2017 to its consignees. The notification described the product, problem and actions to be taken. Notifications were sent to consignees with the following instructions: 1. Immediately identify and quarantine all unused products listed below in a manner that ensures the affected products will not be used. 2. Review, complete, sign and return the attached Business Reply Form to your local DePuy Synthes sales organization in accordance with the directions on the form within 5 bus |
| Quantity | 1972 |
| Distribution | International Distribution (outside the U.S.) only: Mexico, Canada, Ireland, Great Britain, Malaysia, Germany, Austria, Colombia, Spain, Austria, Switzerland, Australia, Hungary, Croatia, and Sweden. |
| 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 |