VADER Pedicle System Torque Wrench Recalled for Out-of-Specification Calibration
Icotec Ag is recalling six VADER Pedicle System Torque Wrench devices due to a calibration error where the torque limiting function was found to be out of specification, delivering 4 Nm instead of the specified 12 Nm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves a surgical instrument with an out-of-specification malfunction that could potentially cause improper device function during use. Although no injuries or illnesses have been reported and the issue was detected before clinical use, the risk of harm in spinal surgical applications warrants a High severity classification.
Plain-English summary
Icotec Ag is recalling 6 VADER Pedicle System Torque Wrench devices (model REF 42-702 with Hudson Coupling) due to a malfunction in the torque limiting function. During internal testing at the manufacturer, the devices were found to deliver a torque output of 4 Nm instead of the specified 12 Nm, indicating the torque limiting function is out of specification.
The affected devices were distributed in the state of Georgia. The recalled devices are identified by serial numbers 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, and 200221-045 (UDI/DI: (01) 07640164844589).
No patient injuries or illnesses have been reported. The malfunction was detected during internal manufacturer testing before clinical use.
The recalled product
- Product
- VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
- Manufacturer
- Icotec Ag
- Category
- Medical Device
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI/DI: (01) 07640164844589
- Serial Numbers: 200221-040
- 200221-041
- 200221-042
- 200221-043
- 200221-044
- 200221-045
Distribution
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