Recall Z-1737-2013 ยท MNI Orthosis, Spinal Pedicle Fixation
SpineFrontier, Inc.
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to pr
| Date | Jul 16, 2013 (initiated Dec 30, 2011) |
| Status | Terminated |
| Reason | One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles. |
| Root cause | Vendor change control |
| Action | SpineFrontier issued a Recall Notification to the affected distributor via telephone. The distributor was instructed to return the affected product for a replacement product. |
| Quantity | 2 rods |
| Distribution | USA Nationwide Distribution including the state of TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092420 | KRD1 PEDICLE SCREW SYSTEM Spinefrontier, Inc., Nov 19, 2009 |