FDASeptember 11, 2020device
Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
What to do
FDA enforcement status: Ongoing
Brands named
bien air surgery sabienbien air
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAPDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP2025-03-07
- FDAETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH2025-03-07
- FDAPROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM2025-03-07
- FDAPDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-12025-03-07
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