Recall Z-2945-2020 ยท HRS Plate, Fixation, Bone
Smith & Nephew, Inc.
EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.
| Date | Aug 24, 2020 |
| Status | Terminated |
| Reason | Multiple or incorrect expiration dates were provided on the affected designation labels. |
| Root cause | Error in labeling |
| Action | On August 24th the firm sent via email a notification to affected consignees. Consignees are asked to inspect inventory, locate and quarantine affected devices. Sales Reps and or distributors are instructed to notify customers of the field action and ensure required actions are complete. Affected product will be returned to Smith & Nephew. All consignees are asked to complete a Response Form, even if they do not have product to return. |
| Quantity | 71 units |
| Distribution | International Distribution to the countries of Denmark, Sweden, France and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140814 | EVOS MINI-FRAGMENT PLATING SYSTEM Smith & Nephew, Inc., May 7, 2014 |