Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0728-2023 · Posted 2022-12-19

Recalling FirmIcotec Ag
Recall StatusTerminated
Product CodeNKB
Date Initiated2022-11-03
Date Terminated2026-09-10
Product Quantity6 devices

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution in the state of GA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020-10-13K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2020-05-22K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019-06-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑