Recall Z-1752-2015— Gyrus Acmi, Incorporated

Name: FDA recall Z-1752-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-08

Class II · Terminated

Class II FDA medical device recall by Gyrus Acmi, Incorporated, initiated 2015-05-08, terminated 2016-05-17. It names one FDA 510(k) clearance: K123429. 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 & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO. Reason: Potential lack of sterility assurance..

Recalling firm: Gyrus Acmi, Incorporated
Classification: Class II
Status: Terminated
Initiated: 2015-05-08
Terminated: 2016-05-17
Firm location: Southborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K123429 — OLYMPUS ENERGY POWER SYSTEM (EPS)Gyrus Acmi, Inc.·cleared 2013-04-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO

Reason for recall

Potential lack of sterility assurance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.