FDA Device recall Z-2767-2015
NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue
- FDA Device
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue by Nico, citing 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 termina….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2767-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-29 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nico |
| Distribution | CA, IN, MD, NC |
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.
Reason
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.
Identifiers
| code_info | Model number NN-7000 SN: 00231, 00232, 00242, 00245, 00248, 00250 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2767-2015%22
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