SpineFrontier, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0554-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.

Product Classification:

Class II

Date Initiated: November 20, 2013

Date Posted: January 1, 2014

Recall Number: Z-0554-2014

Event ID: 66873

Reason for Recall:

Screw inserters may not mate properly with hex interface of the screws.

Status: Terminated

Product Quantity: 25

Code Information:

VM 13194-34457

Distribution Pattern:

US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .

Voluntary or Mandated:

Voluntary: Firm initiated