Z-2767-2015Class II

NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for...

Name: Z-2767-2015 NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for...
Creator: Nico Corp.
Published: 2015-07-29
License: https://open.fda.gov/license/

Nico Corporation / initiated 2015-07-29 / Terminated / root cause: manufacturing process

FDA source

Nico Corp. began a recall of NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of... on 2015-07-29. FDA classified it as Class II and gives the reason as "Two cables within the console were inadvertently twisted during manufacturing. The individual wires within the cables may break and/or contact one another where the cables terminate into two connectors. When these wires...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2767-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-29
Posted: 2015-09-15
Terminated: 2015-09-22
Recalling firm: Nico Corporation
Product: NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.
Product code: GEY Motor, Surgical Instrument, Ac-Powered
Reason for recall: Two cables within the console were inadvertently twisted during manufacturing. The individual wires within the cables may break and/or contact one another where the cables terminate into two connectors. When these wires break or contact one another (i.e., short), various types of malfunction may occur with the console. One type of malfunction may result in unexpected aspiration increase.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Nico Corporation, sent an "URGENT: NICO Console Recall" notification dated 7/31/15 via fax to its customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The customers were instructed to return the console and complete and return the Recall Response Form via fax to: 317-683-0305 or email to: [email protected]. The firm will provide customers with a Myriad Console loaner kit. If you have any questions, contact Director of Quality and Regulatory, at 317-660-7118 ext 104 or email to: [email protected].
Quantity in commerce: 6 units
Distribution: US Distribution to states of: MD, IN, CA, and NC.
Product codes and lots: Model number NN-7000 SN: 00231, 00232, 00242, 00245, 00248, 00250

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2767-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2767-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-15

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)