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