GENICON EZEE Retrieval, sterile, Rx only.
This recall has been terminated (originally issued July 19, 2017).
- Company
- Genicon, Inc.
- Recall Initiated
- July 19, 2017
- Terminated
- May 18, 2020
- Recall Number
- Z-1076-2018
- Quantity
- 2,967 units
- Firm Location
- Winter Park, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.
Distribution
Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.
Lot / Code Info
Catalog No. 550-000-000; Lot No. I8095/2017-11-08, I8162-2018-01-09, I8162/2020-01-09; UDI: 00877972005223.
Root Cause
Device Design
Action Taken
Consignees were notified via email on 07/19/2017. Instructions included
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