Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 recallZ-1926-2013 · SpineFrontier, Inc. · initiated Mar 14, 2013
Class II Terminated All recalls posted in August 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from SpineFrontier, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1926-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 14, 2013
- Posted by the FDA
- Aug 8, 2013
- Recalling firm
- SpineFrontier, Inc.
- Quantity
- 8
- Product code
- HXX
- FDA submissions
- K092420
- Distribution
- Distribution only in Texas.
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 .
Code information (models, lots, serial numbers)
Lot Number: PM3979
Other devices under the same FDA submission
1 device cleared under K092420 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PedFuse® 01-80101Spinefrontier, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page