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StabilICE

ACUTUS MEDICAL, INC. · Model 900218 · UDI-DI 00850027837529

HYADWS Prescription
0
510(k) clearances
11
Adverse events (1 deaths)
1
Recalls
107
Facilities

Description

StabilICE

Recalls

DateFirmReason
2015-06-17Biomet, Inc.Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.

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

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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.