VADER Pedicle System Torque Wrench recall
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Why was VADER Pedicle System Torque Wrench 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045
- Product
- VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
- Recalling firm
- Icotec Ag
- Quantity
- 6 devices
- Distribution
- US Nationwide distribution in the state of GA.
- Recall date
- December 28, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)