SpineFrontier, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1869-2013)

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:

Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients

Product Classification:

Class II

Date Initiated: October 5, 2012

Date Posted: August 7, 2013

Recall Number: Z-1869-2013

Event ID: 64987

Reason for Recall:

Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.

Status: Terminated

Product Quantity: 11 caddies

Code Information:

31176, 018652, 018645R, 42011

Distribution Pattern:

US distribution in states of: CO, DC, MA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated