Recall Z-1874-2018 ยท HRS Plate, Fixation, Bone
Epic Extremity, LLC
Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
| Date | Mar 20, 2018 |
| Status | Terminated |
| Reason | There is an error in the caddy artwork that misidentifies a specific plate and screw. |
| Root cause | Error in labeling |
| Action | Notification letters were sent on 3/20/18. The letters instructed customers to: We ask you to be aware of the incorrect numbers and ensure you are ordering the correct part numbers until replacement parts are available. You will be informed promptly of the availability of the replacement trays. You will be contacted to arrange return and to exchange the parts presently in your possession. Our records indicate that you have received one or more of the trays involved. Therefore, we would ask you to reply to this memo and confirm the quantities of each tray in your possession. Your response w |
| Quantity | 6 units |
| Distribution | The products were distributed to the following US states: FL, PA, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153340 | Epic Extremity Plate System Epic Extremity, LLC, Feb 9, 2016 |