Device product

GENICON EZEE Retrieval, sterile, Rx only.

Z-1076-2018

July 19, 2017

Class II

Product summary

Firm: Genicon, Inc.
Event: Event 78655
Status: Terminated
Classification: Class II
Quantity: 2,967 units
Official record key: device-enforcement:Z-1076-2018

Official wording

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

Code information: Catalog No. 550-000-000; Lot No. I8095/2017-11-08, I8162-2018-01-09, I8162/2020-01-09; UDI: 00877972005223.

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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