Z-0576-2014Class II

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

Name: Z-0576-2014 Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical...
Creator: SpineFrontier, Inc.
Published: 2013-11-20
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2013-11-20 / Terminated / root cause: packaging

FDA source

SpineFrontier, Inc. began a recall of Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position on 2013-11-20. FDA classified it as Class II and gives the reason as "Mismarked and unmarked screws". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0576-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-20
Posted: 2013-12-26
Terminated: 2018-09-06
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Mismarked and unmarked screws
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On 11/20/2013, consignees were notified of the email via letter. Consignees were instructed to return the screws listed in the recall notification letter and return the Recall Acknowledgement form to SpineFrontier via fax or email.
Distribution: Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
Product codes and lots: Lot/Serial Number: IM71013-01: Lot 0000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0576-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0573-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-26
Z-0574-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-26
Z-0575-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-26
Z-0576-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-26

Product code KWQ

K121060Class IISpine Frontier Indus Acp SystemSpinefrontier, Inc. / cleared 2012-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)