Recall Z-2719-2014 ยท GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
St. Jude Medical, Inc.
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
| Date | Sep 29, 2014 (initiated Jul 29, 2014) |
| Status | Terminated |
| Reason | The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals. |
| Root cause | Packaging process control |
| Action | A field action was initiated with customer letters, dated July 29, 2014, and attached replacement DFUs. The letter identified the affected product and the reason for the recall. The recalling firm requested the consignees refer to the replacement DFU for guidance while using the device, and to discard the international manuals. Questions regarding the letter should be directed to customers' St. Jude Neuromodulation Representative or call the Technical Services Department at 1-800-727-7846. |
| Quantity | 4 units |
| Distribution | Distributed in the states of Texas and Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123299 | MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS St. Jude Medical Neuromodulation, Jan 18, 2013 |