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Recall Observatory FDA recall evidence

Device product

Myriad handpiece Tissue morcellator

Z-2045-2016

February 24, 2014

Class II

Product summary

Firm
Nico Corp.
Event
Event 74191
Status
Terminated
Classification
Class II
Quantity
63 units
Official record key
device-enforcement:Z-2045-2016

Official wording

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.

Code information: 13ga, 13cm Myriad Handpiece Part number: NN-8004 Lots 1444664 and 1508994

Distribution pattern: US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.