FDA Device Intelligence
Home › icotec AG › VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 5.5 x 35 mm

VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 5.5 x 35 mm

icotec AG · Model 16-6022-55535 · UDI-DI 07640164844657

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

Description

VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 5.5 x 35 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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.