Recall Z-0701-2024 · PML Bone Cement, Posterior Screw Augmentation
Icotec Ag
VADER pedicle system, torque wrench, Catalog Number 42-703
| Date | Jan 10, 2024 (initiated Nov 28, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Other |
| Action | 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 |
| Distribution | US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222789 | VADER® Pedicle System, G21 Cement Icotec AG, Jan 9, 2023 |