Recall Z-1926-2013 ยท HXX Screwdriver
SpineFrontier, Inc.
Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used d
| Date | Aug 8, 2013 (initiated Mar 14, 2013) |
| Status | Terminated |
| Reason | Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter. |
| Root cause | Device Design |
| Action | Spine Frontier sent an email dated December 10, 2012, to the affected customers that a Pedfuse Inserter with part number PM3979 needed to be returned. Further questions please call (978) 232-3990. |
| Quantity | 8 |
| Distribution | Distribution only in Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092420 | KRD1 PEDICLE SCREW SYSTEM Spinefrontier, Inc., Nov 19, 2009 |