FDAMay 8, 2015device
Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below; Rx Only, STERILE EO
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential lack of sterility assurance.
What to do
FDA enforcement status: Terminated
Brands named
gyrus acmigyrus
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC2019-03-08
- FDAOlympus Diego Elite Console MDCONS 1002019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS2019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS2019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS2019-03-08
- FDADiego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA2019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC2019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC2019-03-08
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