Myriad handpiece Tissue morcellator

FDA Device Recall #Z-2045-2016 — Class II — February 24, 2014

Recall Summary

Recall Number Z-2045-2016
Classification Class II — Moderate risk
Date Initiated February 24, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Nico Corp.
Location Indianapolis, IN
Product Type Devices
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.

Lot / Code Information

13ga, 13cm Myriad Handpiece Part number: NN-8004 Lots 1444664 and 1508994

Other Recalls from Nico Corp.

Recall # Classification Product Date
Z-1840-2021 Class II Myriad-LX Light Source-for delivery of light to... Apr 30, 2021
Z-1839-2021 Class II NICO Myriad-LX Illumination Pack: REF: NN-1000... Apr 30, 2021
Z-2822-2018 Class II NICO Shepherd' s Hook - Greenberg, sterile. An ... Jun 19, 2018
Z-2767-2015 Class II NICO Myriad Console Model number NN-7000 T... Jul 29, 2015
Z-2201-2012 Class II 13.5 mm x 60 mm BrainPath Sheath The NICO Br... Jul 17, 2012

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.