FDA Device recall Z-0728-2023
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
- FDA Device
- Class II
- ongoing
- Published 2022-12-28
On 2022-12-28 the FDA classified a Class II recall of VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 by Icotec Ag, citing during internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0728-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-03 |
| Published | 2022-12-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Icotec Ag |
| Distribution | US |
Product
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Reason
During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.
Identifiers
| code_info | UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0728-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.