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Terminated

Myriad handpiece Tissue morcellator

FDA Recall Z-2045-2016 · Posted None

Recalling FirmNico Corp.
Recall StatusTerminated
Product CodeGEY
Date Initiated2014-02-24
Date Terminated2016-06-28
Product Quantity63 units

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.

Firm Action

NICO sent an Urgent: NICO Myriad Handpiece Recall Notification on February 24, 2014, to all affected customers requesting return of the affected product. The recall notification included a description of the reason for the recall, affected product, customer responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this matter, please call (317) 660-7118, ext. 104.

Root Cause

Device Design

Distribution Pattern

US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955168SURGICAL CUTTERPromex, Inc. · 1996-01-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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