SpineFrontier, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1665-2013)

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:

S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA

Product Classification:

Class II

Date Initiated: May 24, 2013

Date Posted: July 10, 2013

Recall Number: Z-1665-2013

Event ID: 65429

Reason for Recall:

The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.

Status: Terminated

Product Quantity: 12 devices

Code Information:

Lot/Serial Numbers: 47175

Distribution Pattern:

USA Nationwide Distribution including the states of: FL, TX, OK, MO, NJ, MA

Voluntary or Mandated:

Voluntary: Firm initiated