Z-1753-2015Class II

Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone...

Name: Z-1753-2015 Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone...
Creator: Gyrus Acmi, Incorporated
Published: 2015-05-08
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2015-05-08 / Terminated / root cause: sterility

FDA source

Gyrus Acmi, Incorporated began a recall of Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT... on 2015-05-08. FDA classified it as Class II and gives the reason as "Potential lack of sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1753-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-08
Posted: 2015-06-11
Terminated: 2016-05-17
Recalling firm: Gyrus ACMI, Inc.
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
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Potential lack of sterility assurance.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: The firm notified their direct accounts of the recall by Fed Ex Second Day on 05/08/2015. The letter requesting disposal of the product was extended to hospitals or medical practices that purchased the product. Non-responding consignees will be contacted again if necessary.
Quantity in commerce: 22,250 boxes
Distribution: Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain
Product codes and lots: Lot Number: JC24165

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1753-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1752-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-11
Z-1753-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-11

Product code GEI

K123429Class IIOlympus Energy Power System (Eps)Gyrus Acmi, Inc. / cleared 2013-04-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)