Icotec Ag Recall 93577
Description: VADER pedicle system, torque wrench, Catalog Number 42-702
Icotec Ag Recall 93577 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0700-2024 |
| Event ID | 93577 |
| Event Description | VADER pedicle system, torque wrench, Catalog Number 42-702 |
| Product Type | Devices |
| Distribution | US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA |
| Quantity | 79 devices (US only) |
| Recall 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. |
| Device Classification | 20240117 |
| Device Code Info | 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 |
| Center Classification Date | 20240110 |
| Recall Initiation Date | 20231128 |
| Recalling Firm | Icotec Ag |
| Initial Notification | |
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