Recall Z-1597-2015 ยท NKB Thoracolumbosacral Pedicle Screw System
Spinal Elements, Inc
Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Lordosed rods are pre-curved to better fit the p
| Date | May 11, 2015 (initiated Apr 9, 2015) |
| Status | Terminated |
| Reason | Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device. |
| Root cause | Under Investigation by firm |
| Action | The firm sent customer notification letters on 04/09/15. In this letter the firm requested that all affected lots be returned, and replacement inventory will be made available. The firm requested that customers take the following actions: 1. Immediately examine inventory for part number 60100-045. 2. Immediately discontinue the use and/or distribution of the affected lots 3. Send all affected product back to: Spinal Elements, Inc. ATTN: Julie Lamothe 3115 Melrose Drive Carlsbad, CA 92010 4. If further distributed the product to please identify the customers and notify them as once. 5. C |
| Quantity | 588 |
| Distribution | Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071914 | MERCURY SPINAL SYSTEM Spinal Elements, Inc., Oct 12, 2007 |