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FDA (Device enforcement)Recalled 2022-11-03class ii

Icotec Ag: VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the state of GA. Quantity: 6 devices Lot/code info: UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045

UPC codes

07640164844589

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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