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Gyrus Acmi, Incorporated recalls Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft an
Recalled June 17, 2015 · FDA recall Z-1753-2015 · Gyrus Acmi, Incorporated
Hazard
Potential lack of sterility assurance. · FDA Class II
Units
22,250 boxes
Sold at
Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain
Description
Potential lack of sterility assurance.
Product
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
Manufacturer(s)
Gyrus Acmi, Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →