Recall Z-1076-2018
Genicon, Inc. · initiated July 19, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
GENICON EZEE Retrieval, sterile, Rx only.
Codes / lots: Catalog No. 550-000-000; Lot No. I8095/2017-11-08, I8162-2018-01-09, I8162/2020-01-09; UDI: 00877972005223.
Reason for recall
Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.
FDA-determined cause: Device Design
Action taken
Consignees were notified via email on 07/19/2017. Instructions included
Details
- Recall number
- Z-1076-2018
- Initiated
- July 19, 2017
- Terminated
- May 18, 2020
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Quantity
- 2,967 units
- Distribution
- Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.
- Recalling firm
- Genicon, Inc., Winter Park, FL