--- title: "VADER pedicle system, torque wrench, Catalog Number 42-702 — FDA record Z-0700-2024 | Is It on Recall" description: "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" url: https://isitonrecall.com/recall/fda-device-z-0700-2024-vader-pedicle-system-torque-wrench-catalog-number-42-702/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # VADER pedicle system, torque wrench, Catalog Number 42-702 — FDA record Z-0700-2024 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Nov 28, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: VADER pedicle system, torque wrench, Catalog Number 42-702 - **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. - **Classification**: Class II - **Recalling firm**: Icotec Ag - **Quantity**: 79 devices (US only) - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0700-2024 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0700-2024%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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 | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Michigan](https://isitonrecall.com/state/michigan/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Texas](https://isitonrecall.com/state/texas/) ## Dates in the source - **Report date**: Jan 17, 2024 - **Recall initiation date**: Nov 28, 2023 - **Center classification date**: Jan 10, 2024 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0700-2024%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Icotec Ag records](https://isitonrecall.com/brand/icotec-ag/)