SpineFrontier, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1479-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.

Product Classification:

Class II

Date Initiated: March 5, 2015

Date Posted: April 29, 2015

Recall Number: Z-1479-2015

Event ID: 70488

Reason for Recall:

The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.

Status: Terminated

Product Quantity: 5 devices

Code Information:

Revision E

Distribution Pattern:

US Nationwide Distribution in the states of TX, KS, CO, and MA

Voluntary or Mandated:

Voluntary: Firm initiated