FDA-Device2016-06-29Class II
Myriad handpiece Tissue morcellator
Nico Corp.
Hazard
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.
Sold states
US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.
Affected count
63 units
Manufactured in
250 E 96th St Ste 125, N/A, Indianapolis, IN, United States
Products
Myriad handpiece Tissue morcellator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2045-2016Don't want to check this manually?
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