Icotec Ag 2022-12-28 Health serious FDA
Health · FDA · Recall #FDA-Z-0728-2023
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 Recall
Issued December 28, 2022 · Icotec Ag
In December 2022, Icotec Ag recalled the VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Icotec Ag to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Icotec Ag
- Category
- Health
- Recall date
- December 28, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the state of GA.
- Recall number
- FDA-Z-0728-2023
- Made in
- Switzerland
- Issuing agency
- FDA
In context
- Icotec Ag has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.