Z-1479-2015Class II

SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod...

Name: Z-1479-2015 SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod...
Creator: SpineFrontier, Inc.
Published: 2015-03-05
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2015-03-05 / Terminated / root cause: labeling and UDI

FDA source

SpineFrontier, Inc. began a recall of SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be... on 2015-03-05. FDA classified it as Class II and gives the reason as "The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1479-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-05
Posted: 2015-04-21
Terminated: 2015-06-15
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.
Product code: FTY Tape, Measuring, Rulers And Calipers
Reason for recall: The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: SpineFrontier sent an Urgent Advisory Notice letter to customers via email. The letter identified the affected product, problem and actions to be taken. Customers were asked complete and return the Acknowledgement Form to confirm receipt of the recall notification. For questions call 978-232-3990.
Quantity in commerce: 5 devices
Distribution: US Nationwide Distribution in the states of TX, KS, CO, and MA
Product codes and lots: Revision E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1479-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1479-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-21

Product code FTY

K123164Class IISpinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. / cleared 2013-02-15

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)