Recall Z-1261-2013 ยท NKB Thoracolumbosacral Pedicle Screw System
Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
| Date | May 7, 2013 (initiated Apr 17, 2009) |
| Status | Terminated |
| Reason | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Root cause | Nonconforming Material/Component |
| Action | Spinal Elements sent Urgent Medical Device Recall notification letters to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Chief Technology Officer at Spinal Elements for questions about the recall letter. |
| Quantity | 68 units total |
| Distribution | Distributed in OH and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071914 | MERCURY SPINAL SYSTEM Spinal Elements, Inc., Oct 12, 2007 |