Z-0700-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 17, 2024
- Initiation Date
- November 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 79 devices (US only)
Product Description
VADER pedicle system, torque wrench, Catalog Number 42-702
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 Pattern
US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA
Code Information
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, 200131-73, 200131-74, 200221-040R1, 200424-01, 200424-03, 200424-04, 200424-05, 200424-06, 200424-10, 200424-11, 200424-12, 200424-13, 200424-14, 200424-15, 200424-16, 200424-17, 200424-20, 200424-21, 200424-22, 200424-24, 200424-25, 200424-27, 200424-29, 200424-32, 200424-34, 200424-35, 200605-051R1, 200605-052R1, 201002-073R1, 210915-005, 210915-009, 210915-010, 210915-011, 210915-012, 220610-001, 220610-003, 220610-008, 220610-019, 220610-020, 220610-021, 220610-025, 220610-026, 220610-030, 230113-003, 230113-005, 230113-007, 230113-008, 230113-009, 230113-010, 230113-011, 230113-012, 230113-013, 230113-014, 230224-029, 230224-034, 230426-038, 230426-039, 230426-042, 230426-043