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Recall Observatory FDA recall evidence

Device product

VADER pedicle system, torque wrench, Catalog Number 42-703

Z-0701-2024

November 28, 2023

Class II

Product summary

Firm
Icotec Ag
Event
Event 93577
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0701-2024

Official wording

Reason: icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.

Code information: 220803-001, 220803-002, 220803-003

Distribution pattern: US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.