Recall Z-0573-2014— SpineFrontier, Inc.

Name: FDA recall Z-0573-2014
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: IM71058-XX: 04.2mm, SelfTapping, Tapered. 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: IM71058-XX: 04.2mm, SelfTapping, Tapered. 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.