FDA Recall
Open, Classified
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Recall: Z-0728-2023
·
Initiated November 3, 2022
Recall
- Recall Number
- Z-0728-2023
- Event Number
- 91174
- Firm
- Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland
- FEI Number
- 3006493760
- Product Code
- NKB
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 3, 2022
- Posted
- December 19, 2022
Description
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
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.
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.
Distribution
US Nationwide distribution in the state of GA.
Quantity
6 devices