NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation o
FDA device recall Z-2767-2015 · posted 2015-09-15 · Terminated
Recall details
- Recalling firm
- Nico Corp.
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEY
- Quantity affected
- 6 units
- Distribution
- US Distribution to states of: MD, IN, CA, and NC.
- Date initiated
- 2015-07-29
- Date posted
- 2015-09-15
- Date terminated
- 2015-09-22
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGICAL CUTTER (K955168) | Promex, Inc. | 1996-01-22 |