VADER Pedicle System Torque Wrench Recalled Due to Defective Tightening Function
Icotec is recalling VADER pedicle system torque wrenches because the torque limiting function can malfunction, potentially leaving screw fasteners insufficiently tightened during implant surgery.
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: FDA Class II medical device with a mechanical defect affecting a surgical implant system. No injuries or hospitalizations are reported, so the score does not exceed the High category despite the serious potential risk to implant stability.
Plain-English summary
Icotec Ag is recalling the VADER pedicle system torque wrench (Catalog Number 42-703, batch codes 220803-001, 220803-002, 220803-003). The VADER pedicle system is a surgical device used during spinal implant surgery.
The torque limiting function of the torque wrench did not function correctly. Due to this malfunction, the nut screws used in the procedure may not have been tightened sufficiently.
The affected devices were distributed in the United States to Arizona, California, Colorado, Delaware, Michigan, New York, North Carolina, Ohio, Pennsylvania, and Texas.
Icotec identified the issue during an investigation into one revision case where nut screws had become loose. The defect affects batch codes 220803-001, 220803-002, and 220803-003.
The recalled product
- Product
- VADER pedicle system, torque wrench, Catalog Number 42-703
- Manufacturer
- Icotec Ag
- Hazard
- loose-fastener
- torque-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 (3)
- 220803-001
- 220803-002
- 220803-003
Distribution
Distributed in 10 states:
- AZ
- CA
- CO
- DE
- MI
- NC
- NY
- OH
- PA
- TX
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