FDA Device recall Z-2045-2016
Myriad handpiece Tissue morcellator
- FDA Device
- Class II
- terminated
- Published 2016-06-29
On 2016-06-29 the FDA classified a Class II recall of Myriad handpiece Tissue morcellator by Nico, citing 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 wit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2045-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-24 |
| Published | 2016-06-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nico |
| Distribution | AR, CA, GA, IA, IL, IN, MD, MI, NC, OH, OR, TX, WI |
Product
Myriad handpiece Tissue morcellator
Reason
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.
Identifiers
| code_info | 13ga, 13cm Myriad Handpiece Part number: NN-8004 Lots 1444664 and 1508994 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2045-2016%22
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