Recall Z-2767-2015
Nico Corp. · initiated July 29, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model number NN-7000 SN: 00231, 00232, 00242, 00245, 00248, 00250
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: Process control
Action taken
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.
Details
- Recall number
- Z-2767-2015
- Initiated
- July 29, 2015
- Posted by FDA
- September 15, 2015
- Terminated
- September 22, 2015
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Quantity
- 6 units
- Distribution
- US Distribution to states of: MD, IN, CA, and NC.
- Recalling firm
- Nico Corp., Indianapolis, IN