Reported Jun 29, 2016 · Terminated
Myriad handpiece Tissue morcellator
Nico Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nico Corp. · 250 E 96th St Ste 125 · Indianapolis, IN · 46240-3872
Is this the product you have?
- Myriad handpiece Tissue morcellator
- Lot codes and dates
13ga13cm
- Myriad Handpiece Part numberNN-8004 Lots 1444664 and 1508994
- Amount recalled
- 63 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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