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ACTEON

SATELEC · Model 03.000.408S · UDI-DI 03609820877150

JDX Prescription
1
510(k) clearances
176
Adverse events
2
Recalls
38
Facilities

Description

Non-cutting spatula, oriented at 135°, used for sinus membrane elevation inside the sinus and for disengagement of anatomical structures. Spatula diameter: 4 mm. Alternative DI : 10887587009759

Recalls

DateFirmReason
2019-06-04Zimmer Biomet, Inc.The products do not have sufficient data to support the labeled shelf life of 10 years.
2019-06-04Zimmer Biomet, Inc.The products do not have sufficient data to support the labeled shelf life of 10 years.

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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.