Recall Z-2045-2016— Nico Corp.
Class II · Terminated
Class II FDA medical device recall by Nico Corp., initiated 2014-02-24, terminated 2016-06-28. It names one FDA 510(k) clearance: K955168. 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..
- Recalling firm
- Nico Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-24
- Terminated
- 2016-06-28
- Firm location
- Indianapolis, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.