Z-1973-2019Class II

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

Name: Z-1973-2019 A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
Creator: SpineFrontier, Inc.
Published: 2019-06-13
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2019-06-13 / Terminated / root cause: manufacturing process

FDA source

SpineFrontier, Inc. began a recall of A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106) on 2019-06-13. FDA classified it as Class II and gives the reason as "There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1973-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-13
Posted: 2019-07-12
Terminated: 2020-05-11
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
Product code: OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Reason for recall: There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Medical Device Recall letters dated 6/13/19 were emailed to customers.
Quantity in commerce: 6
Distribution: The products were distributed to the following US states: AZ, MD, MO, and FL.
Product codes and lots: Lot EC20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1973-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1973-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-12

Product code OVE

K172484Class IIA-CIFT SoloFuseSpinefrontier, Inc. / cleared 2018-05-08

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)