VADER pedicle system, torque wrench, Catalog Number 42-703
- Recall Initiated
- November 28, 2023
- Posted
- January 10, 2024
- Recall Number
- Z-0701-2024
Reason for Recall
icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.
Distribution
US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA
Lot / Code Info
220803-001, 220803-002, 220803-003
Root Cause
Other
Action Taken
icotec ag issued an URGENT Medical Device Recall notice to its consignees beginning on 11/28/2023 via email. The notice explained the problem with the device, the risk to health, and informed the medical facility that the affected product had been removed prior to the notice. Decision on whether patient-level follow-up is required should be made by the physician. Replacements will be provided where applicable. The firm expanded this recall on 12/27/2023 (notices delivered by US mail) to include additional lots and one additional product. Contact for questions: Laura Husken, laura.huesken@icotec.ch, Tel.: +41 78 438 78 73