FDA Device recall Z-1926-2013
Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw asse…
- FDA Device
- Class II
- terminated
- Published 2013-08-14
On 2013-08-14 the FDA classified a Class II recall of Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw asse… by Spinefrontier, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1926-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-14 |
| Published | 2013-08-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | TX |
Product
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
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.
Identifiers
| code_info | Lot Number: PM3979 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1926-2013%22
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