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U.S. Department of Health and Human Services

Class 2 Device Recall Nico Myriad

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  Class 2 Device Recall Nico Myriad see related information
Date Initiated by Firm July 29, 2015
Date Posted September 15, 2015
Recall Status1 Terminated 3 on September 22, 2015
Recall Number Z-2767-2015
Recall Event ID 72015
510(K)Number K955168  
Product Classification Motor, surgical instrument, ac-powered - Product Code GEY
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.
Code Information Model number NN-7000  SN: 00231, 00232, 00242, 00245, 00248, 00250
Recalling Firm/
Manufacturer		 Nico Corp.
250 E 96th St
ste 125
Indianapolis IN 46240-3781
For Additional Information Contact NICO Corporation
317-660-7118
Manufacturer 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.
FDA Determined
Cause 2		 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: Jay.Dittman@niconeuro.com. 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: jay.dittman@nicneuro.com.
Quantity in Commerce 6 units
Distribution US Distribution to states of: MD, IN, CA, and NC.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEY and Original Applicant = PROMEX, INC.
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