Recall Z-1156-2013 ยท MNI Orthosis, Spinal Pedicle Fixation
Orthopedic Alliance LLC
Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod 5.5 x 40mm BGR0050 Straight Rod 5.5 x 50mm BGR0060 Straight Rod 5.5 x 60mm BGR0070 Straight Rod 5.5 x 70mm BGR0080 Straight Rod 5.5 x 80mm BGR0090 Straight Rod 5.5 x 90mm BGR0100 Straight Rod 5.5 x 100mm BGR0110 Straight Rod 5.5 x 110mm BGR0120 Straight Rod 5.5 x 120mm BGR0130 Straight Rod
| Date | Apr 22, 2013 (initiated Mar 7, 2013) |
| Status | Terminated |
| Reason | Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product peformance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization. |
| Root cause | Device Design |
| Action | A recall letter dated March 7, 2013 was sent to one customer who purchased the Blue & Gold Implants and instruments. The letter informed the customer that the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product performance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization. Customer is informed of the actions to be taken. Customer is instructed to complete the customer response form and return it by FAX to (858) 76 |
| Quantity | 3,300 units |
| Distribution | Distributed in Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033826 | ORTHOPEDIC ALLIANCE SPINE SYSTEM Orthopedic Alliance, LLC, Jul 1, 2004 |