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GYRUS ACMI

Gyrus ACMI, LLC · Model 5720000 · UDI-DI 00821925009783

FGO Prescription
10
510(k) clearances
315
Adverse events (1 deaths)
3
Recalls
29
Facilities

Description

Surlok Stone Grasping Forceps 2.4 FR (0.8 mm) X 90 cm Basket Width: 16 mm # of Wires: 3

Recalls

DateFirmReason
2011-11-14US Endoscopy Group IncWhen the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become
2003-06-30Scion Cardio-Vascular, Inc.The firm received field complaints that it was difficult to open the stone retrieval basket during use.
2003-05-23Scion Cardio-Vascular, Inc.Possible difficulty for the user in opening the stone retrieval basket.

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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.