FDA Medical Device Recalls (openFDA)
Icotec Ag: VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
- Recall number
- Z-0728-2023
- Recalling firm
- Icotec Ag
- Product
- VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
- Status
- Open, Classified
- Initiated
- 2022-11-03
- Posted
- 2022-12-19
- Terminated
- not on file
- Reason
- 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
- 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
- 6 devices
- Distribution
- US Nationwide distribution in the state of GA.
- Lot, serial or model codes
- UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045
- 510(k) numbers
- ["K190545","K193423","K200596"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3006493760
- Firm city
- Altstatten Sg
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28