SpineFrontier, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1957-2013)

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:

Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.

Product Classification:

Class II

Date Initiated: May 9, 2012
Date Posted: August 21, 2013
Recall Number: Z-1957-2013
Event ID: 64994
Reason for Recall:

The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.

Status: Terminated
Product Quantity: 9
Code Information:

Lot Number: 011836-0001, 011981-001

Distribution Pattern:

Distributed in DC and the states of MA, and OK.

Voluntary or Mandated:

Voluntary: Firm initiated