SpineFrontier, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0544-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

Product Classification:

Class II

Date Initiated: October 18, 2013

Date Posted: December 25, 2013

Recall Number: Z-0544-2014

Event ID: 66698

Reason for Recall:

During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.

Status: Terminated

Product Quantity: 35 Devices

Code Information:

Lot/Serial Numbers: 357305-000

Distribution Pattern:

US Distribution to VA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated