Z-2767-2015 Class II Terminated
FDA device recall Z-2767-2015 was initiated by Nico Corp. on July 29, 2015 and is designated Class II. 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 connector… The recall status is terminated (terminated September 22, 2015). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2015
- Initiation Date
- July 29, 2015
- Termination Date
- September 22, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
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 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.
Distribution Pattern
US Distribution to states of: MD, IN, CA, and NC.
Code Information
Model number NN-7000 SN: 00231, 00232, 00242, 00245, 00248, 00250