Recall Z-1973-2019— SpineFrontier, Inc.

Name: FDA recall Z-1973-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-13

Class II · Terminated

Class II FDA medical device recall by SpineFrontier, Inc., initiated 2019-06-13, terminated 2020-05-11. It names one FDA 510(k) clearance: K172484. Product: A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106). Reason: There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw..

Recalling firm: SpineFrontier, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-06-13
Terminated: 2020-05-11
Firm location: Malden, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K172484 — A-CIFT SoloFuseSpinefrontier, Inc.·cleared 2018-05-08

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

A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)

Reason for recall

There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.

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