Recall Z-2045-2016 ยท GEY Motor, Surgical Instrument, Ac-Powered
Nico Corp.
Myriad handpiece Tissue morcellator
| Date | Feb 24, 2014 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 63 units |
| Distribution | US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955168 | SURGICAL CUTTER Promex, Inc., Jan 22, 1996 |