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Gyrus ACMI

Gyrus ACMI, LLC · Model 140741 · UDI-DI 00821925035478

ETB Prescription
1
510(k) clearances
100
Adverse events
3
Recalls
26
Facilities

Description

Trapeze Ribbon Loop 4.0 mm Length Platinum

Recalls

DateFirmReason
2026-04-03Grace Medical, Inc.Due to incorrect functional length on device labeling.
2020-07-14Olympus Corporation of the AmericasMislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; se
2020-07-14Olympus Corporation of the AmericasMislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; se

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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.