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VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm

icotec AG · Model 42-546-1 · UDI-DI 07640172552902

PMLNKB Prescription
10
510(k) clearances
310
Adverse events (8 deaths)
2
Recalls
80
Facilities

Description

VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm

Recalls

DateFirmReason
2023-11-28Icotec Agicotec 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 th
2023-11-28Icotec Agicotec 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 th

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.