VADER pedicle system torque wrench may not tighten implant screws correctly
Icotec Ag is recalling VADER pedicle system torque wrenches (Catalog Number 42-702) because the torque limiting function may malfunction, potentially leaving nut screws insufficiently tightened during implant surgery. No injuries have been reported.
What this means for you
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 is an FDA Class II medical device recall involving a documented malfunction of the torque limiting function in a surgical tool used for spinal implantation. While the defect could result in serious complications from inadequate fixation, no illnesses or injuries have been reported. The score reflects the risk-of-harm nature of a malfunction in a critical surgical application.
Plain-English summary
Icotec Ag is recalling 79 VADER pedicle system torque wrenches (Catalog Number 42-702) distributed in the United States. The company received notification of a revision involving loose nut screws and conducted an investigation that identified a malfunction: the torque limiting function of these wrenches was not functioning correctly.
During pedicle screw implantation surgery, this torque wrench is used to tighten nut screws to proper specifications. If the torque limiting function malfunctions, the nut screws may not be tightened sufficiently, potentially compromising the structural integrity of the spinal implant.
The affected devices have been distributed to healthcare facilities in Arizona, Michigan, Ohio, California, Colorado, Texas, New York, North Carolina, Delaware, and Pennsylvania. Icotec Ag has not received reports of injuries or complications associated with this malfunction to date.
Patients who have received VADER pedicle system implants using affected torque wrenches should contact their surgeon. Healthcare providers should immediately cease use of affected wrenches and verify proper torque specifications during future implantations using unaffected equipment. Affected units can be identified by the lot codes referenced in the FDA recall notice.
The recalled product
- Product
- VADER pedicle system, torque wrench, Catalog Number 42-702
- Manufacturer
- Icotec Ag
- Hazard
- torque-malfunction
- fixation-failure
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 (20)
- 19/01-001
- 19/01-013
- 19/01-014
- 19/01-015
- 190830-10
- 190830-23
- 190830-42
- 190830-44
- 190830-45
- 190830-50
- 190830-51
- 190830-52
- 200131-54
- 200131-56
- 200131-62
- 200131-64
- 200131-68
- 200131-69
- 200131-70
- 200131-72
Distribution
Distributed in 10 states:
- AZ
- CA
- CO
- DE
- MI
- NC
- NY
- OH
- PA
- TX
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