Home / Recalls / Nico Corp. / Z-2045-2016

Z-2045-2016 Class II Terminated

Recalled by Nico Corp. — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
June 29, 2016
Initiation Date
February 24, 2014
Termination Date
June 28, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
63 units

Product Description

Myriad handpiece Tissue morcellator

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.

Distribution Pattern

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

Code Information

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

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  • Z-2822-2018 Class II — NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath dev (June 19, 2018)
  • Z-2767-2015 Class II — NICO Myriad Console Model number NN-7000 The Myriad System is a surgical sy (July 29, 2015)
  • Z-2201-2012 Class II — 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products t (July 17, 2012)
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