Z-1750-2018Class II

Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product...

Name: Z-1750-2018 Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2018-03-23
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2018-03-23 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body on 2018-03-23. FDA classified it as Class II and gives the reason as "Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm". 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-1750-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-23
Posted: 2018-05-08
Terminated: 2021-07-25
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated their recall by letter on 03/23/2018. The recall notice requested: "1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via email to [email protected]. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product. "
Quantity in commerce: 39 units
Distribution: Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France
Product codes and lots: GTIN/UPN: 643169329218 Lot Number: H5399679

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1750-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1750-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-08

Product code KWQ

K141632Class IIZevo (Tm) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. / cleared 2014-12-04

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)