Z-2045-2016Class II

Myriad handpiece Tissue morcellator

Name: Z-2045-2016 Myriad handpiece Tissue morcellator
Creator: Nico Corp.
Published: 2014-02-24
License: https://open.fda.gov/license/

Nico Corporation / initiated 2014-02-24 / Terminated / root cause: design

FDA source

Nico Corp. began a recall of Myriad handpiece Tissue morcellator on 2014-02-24. FDA classified it as Class II and gives the reason as "This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail. The failure will result in the inability to cut tissue with the handpiece, rendering it...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2045-2016
Classification: Class II
Status: Terminated
Initiated: 2014-02-24
Posted: 2016-06-21
Terminated: 2016-06-28
Recalling firm: Nico Corporation
Product: Myriad handpiece Tissue morcellator
Product code: GEY Motor, Surgical Instrument, Ac-Powered
Reason for recall: This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail. The failure will result in the inability to cut tissue with the handpiece, rendering it non-functional. Should this failure occur, a replacement Myriad handpiece will be required. If a replacement handpiece is not available, alternate instrumentation for tissue removal will be necessary.
Root cause tag: design
FDA root cause: Device Design
Action: NICO sent an Urgent: NICO Myriad Handpiece Recall Notification on February 24, 2014, to all affected customers requesting return of the affected product. The recall notification included a description of the reason for the recall, affected product, customer responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this matter, please call (317) 660-7118, ext. 104.
Quantity in commerce: 63 units
Distribution: US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.
Product codes and lots: 13ga, 13cm Myriad Handpiece Part number: NN-8004 Lots 1444664 and 1508994

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2045-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2045-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21

Product code GEY

K955168Class IISurgical CutterPromex, Inc. / cleared 1996-01-22

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)