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.
FDA Recall Z-2767-2015 · Posted 2015-09-15
Recalling FirmNico Corp.
Recall StatusTerminated
Product CodeGEY
Date Initiated2015-07-29
Date Terminated2015-09-22
Product Quantity6 units
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.
Firm 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].
Root Cause
Process control
Distribution Pattern
US Distribution to states of: MD, IN, CA, and NC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.