Recall Z-0364-2022 ยท HRS Plate, Fixation, Bone
Smith & Nephew, Inc.
smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
| Date | Nov 1, 2021 |
| Status | Terminated |
| Reason | Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated the correction by email and letter on 1 NOV 2021. The notice explained the problem and requested that the consignees check their inventory and complete the Inventory Correction Certificate form. Distributors were directed to notify their customers of the field action and ensure that these actions are carried out. |
| Quantity | 35 units |
| Distribution | US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201918 | EVOS Large Fragment Plating System Smith & Nephew, Inc., Nov 16, 2020 |