Z-1076-2018 Class II Terminated
FDA device recall Z-1076-2018 was initiated by Genicon, Inc. on July 19, 2017 and is designated Class II. Reason for recall: Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use. The recall status is terminated (terminated May 18, 2020). Affected quantity: 2,967 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- July 19, 2017
- Termination Date
- May 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,967 units
Product Description
GENICON EZEE Retrieval, sterile, Rx only.
Reason for Recall
Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.
Distribution Pattern
Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.
Code Information
Catalog No. 550-000-000; Lot No. I8095/2017-11-08, I8162-2018-01-09, I8162/2020-01-09; UDI: 00877972005223.