Recall Z-1957-2013— SpineFrontier, Inc.

Name: FDA recall Z-1957-2013
Creator: U.S. Food and Drug Administration
Published: 2012-05-09

Class II · Terminated

Class II FDA medical device recall by SpineFrontier, Inc., initiated 2012-05-09, terminated 2014-01-10. It names one FDA 510(k) clearance: K121060. Product: 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.. Reason: The nipple of the tipped driver broke off when surgeons were attempting to insert the screw..

Recalling firm: SpineFrontier, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-05-09
Terminated: 2014-01-10
Firm location: Beverly, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K121060 — SPINE FRONTIER INDUS ACP SYSTEMSpinefrontier, Inc.·cleared 2012-07-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.