Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Brand
Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland
Lot Codes / Batch Numbers
UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045
Products Sold
UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045
Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland is recalling VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 due to During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specificatio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026