Z-1926-2013 Class II Terminated
FDA device recall Z-1926-2013 was initiated by SpineFrontier, Inc. on Mar 14, 2013 and is designated Class II. 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… The recall status is terminated (terminated Jun 3, 2015). Affected quantity: 8.
Recall details
- Product Type
- Devices
- Report Date
- Aug 14, 2013
- Initiation Date
- Mar 14, 2013
- Termination Date
- Jun 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product description
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 .
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.
Distribution pattern
Distribution only in Texas.
Code information
Lot Number: PM3979
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1926-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026