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 during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System .
FDA Recall Z-1926-2013 · Posted 2013-08-08
Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeHXX
Date Initiated2013-03-14
Date Terminated2015-06-03
Product Quantity8
Reason for Recall
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Distribution only in Texas.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.