Z-2045-2016 Class II Terminated
FDA device recall Z-2045-2016 was initiated by Nico Corp. on February 24, 2014 and is designated Class II. 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, re… The recall status is terminated (terminated June 28, 2016). Affected quantity: 63 units.
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