VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm… recallZ-0728-2023 · Icotec Ag · initiated Nov 3, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Icotec Ag or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0728-2023
- Status
- Terminated
- Initiated by the company
- Nov 3, 2022
- Posted by the FDA
- Dec 19, 2022
- Recalling firm
- Icotec Ag
- Quantity
- 6 devices
- Product code
- NKB
- FDA submissions
- K190545, K193423, K200596
- Distribution
- US Nationwide distribution in the state of GA.
Product description
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Code information (models, lots, serial numbers)
UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VADER Pedicle System, Torque Wrench, Hudson Coupling, 12 Nm 42-702icotec AG · Thoracolumbosacral Pedicle Screw System1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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