SpineFrontier, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1932-2013)

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:

T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.

Product Classification:

Class II

Date Initiated: August 29, 2012

Date Posted: August 14, 2013

Recall Number: Z-1932-2013

Event ID: 64993

Reason for Recall:

During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.

Status: Terminated

Product Quantity: 11

Code Information:

Lot Numbers: 1335201A, 1446101A

Distribution Pattern:

US Distribution including the states of MA, NV and TX.

Voluntary or Mandated:

Voluntary: Firm initiated