Recall Z-2045-2016
Nico Corp. · initiated February 24, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Myriad handpiece Tissue morcellator
Codes / lots: 13ga, 13cm Myriad Handpiece Part number: NN-8004 Lots 1444664 and 1508994
Reason for recall
This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail. The failure will result in the inability to cut tissue with the handpiece, rendering it non-functional. Should this failure occur, a replacement Myriad handpiece will be required. If a replacement handpiece is not available, alternate instrumentation for tissue removal will be necessary.
FDA-determined cause: Device Design
Action taken
NICO sent an Urgent: NICO Myriad Handpiece Recall Notification on February 24, 2014, to all affected customers requesting return of the affected product. The recall notification included a description of the reason for the recall, affected product, customer responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this matter, please call (317) 660-7118, ext. 104.
Details
- Recall number
- Z-2045-2016
- Initiated
- February 24, 2014
- Terminated
- June 28, 2016
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Quantity
- 63 units
- Distribution
- US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.
- Recalling firm
- Nico Corp., Indianapolis, IN