Recall Z-0576-2014— SpineFrontier, Inc.

Name: FDA recall Z-0576-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-20

Class II · Terminated

Class II FDA medical device recall by SpineFrontier, Inc., initiated 2013-11-20, terminated 2018-09-06. It names one FDA 510(k) clearance: K121060. Product: Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.. Reason: Mismarked and unmarked screws.

Recalling firm: SpineFrontier, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-20
Terminated: 2018-09-06
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

Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.

Reason for recall

Mismarked and unmarked screws

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