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U.S. Department of Health and Human Services

Class 2 Device Recall Myriad System

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 Class 2 Device Recall Myriad Systemsee related information
Date Initiated by FirmFebruary 24, 2014
Create DateJune 21, 2016
Recall Status1 Terminated 3 on June 28, 2016
Recall NumberZ-2045-2016
Recall Event ID 74191
510(K)NumberK955168 
Product Classification Motor, surgical instrument, ac-powered - Product Code GEY
ProductMyriad handpiece Tissue morcellator
Code Information 13ga, 13cm Myriad Handpiece Part number: NN-8004 Lots 1444664 and 1508994
FEI Number 3007456622
Recalling Firm/
Manufacturer		 Nico Corp.
250 E 96th St Ste 125
Indianapolis IN 46240-3872
For Additional Information ContactJay A. Dittman
317-660-7118 Ext. 104
Manufacturer 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 2		Device Design
ActionNICO 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 in Commerce63 units
DistributionUS Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEY
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