Z-0728-2023Class II

VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

Name: Z-0728-2023 VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Creator: Icotec Ag
Published: 2022-11-03
License: https://open.fda.gov/license/

Icotec AG / initiated 2022-11-03 / Open, Classified / root cause: manufacturing process

FDA source

Icotec Ag began a recall of VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 on 2022-11-03. FDA classified it as Class II and gives the reason as "During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0728-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-03
Posted: 2022-12-19
Recalling firm: Icotec AG
Product: VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Icotec issued a Field Action Notice to its consignee on 11/03/2022 by email. The notice explained the issue and that XXXX. The firm followed with an email to inform the consignee of their intent to recall the device. The notice requested the return of the device from the field. The firm will be replacing the devices.
Quantity in commerce: 6 devices
Distribution: US Nationwide distribution in the state of GA.
Product codes and lots: UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0728-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0728-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-19

Product code NKB

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)