Recall Z-1076-2018 ยท GCJ Laparoscope, General & Plastic Surgery
Genicon, Inc.
GENICON EZEE Retrieval, sterile, Rx only.
| Date | Jul 19, 2017 |
| Status | Terminated |
| Reason | Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use. |
| Root cause | Device Design |
| Action | Consignees were notified via email on 07/19/2017. Instructions included |
| Quantity | 2,967 units |
| Distribution | Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162059 | EZEE RETRIEVAL Genicon, Inc., Sep 29, 2016 |