Z-1941-2020Class II

VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628

Name: Z-1941-2020 VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Creator: Medtronic Sofamor Danek USA Inc
Published: 2020-03-26
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2020-03-26 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 on 2020-03-26. FDA classified it as Class II and gives the reason as "Nonconforming product; length of the product measured shorter than the labeled length". 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-1941-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-26
Posted: 2020-05-08
Terminated: 2021-03-26
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Nonconforming product; length of the product measured shorter than the labeled length.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medtronic, Inc., notified customers on March 31, 2020 via " Urgent Voluntary Market Removal (Recall) Vertex Select Multi Axial Screw (MAS) Product Code 6958838 Lot H5517628. The recall letter identified the affected product and requested the customers to remove the impacted product from normal storage location and complete the return form.
Quantity in commerce: 83 units.
Distribution: US Nationwide distribution in the states of CA and MI.
Product codes and lots: Product no. 6958838. UDI: 00613994354686.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1941-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1941-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-08

Product code KWP

K081297Class IIVertex Reconstruction SystemMedtronic Sofamor Danek / cleared 2008-06-11

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)