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Terminated

GENICON EZEE Retrieval, sterile, Rx only.

FDA Recall Z-1076-2018 · Posted None

Recalling FirmGenicon, Inc.
Recall StatusTerminated
Product CodeGCJ
Date Initiated2017-07-19
Date Terminated2020-05-18
Product Quantity2,967 units

Reason for Recall

Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.

Firm Action

Consignees were notified via email on 07/19/2017. Instructions included

Root Cause

Device Design

Distribution Pattern

Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162059EZEE RETRIEVALGenicon, Inc. · 2016-09-29

Official Source

View FDA Recall →

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

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