Myriad handpiece Tissue morcellator
Reported: June 29, 2016 Initiated: February 24, 2014 #Z-2045-2016
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.
Details
- Recalling Firm
- Nico Corp.
- Units Affected
- 63 units
- Distribution
- US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
Myriad handpiece Tissue morcellator. Recalled by Nico Corp.. Units affected: 63 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 29, 2016. Severity: Moderate. Recall number: Z-2045-2016.
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