VADER pedicle system, torque wrench, Catalog Number 42-703
Recall
- Recall Number
- Z-0701-2024
- Event Number
- 93577
- Firm
- Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland
- FEI Number
- 3006493760
- Product Code
- PML
- Status
- Open, Classified
- Root Cause
- Other
- Initiated
- November 28, 2023
- Posted
- January 10, 2024
Description
VADER pedicle system, torque wrench, Catalog Number 42-703
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.
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, [email protected], Tel.: +41 78 438 78 73
US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA