Smith & Nephew, Inc. Recall 89031
Description: smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
Smith & Nephew, Inc. Recall 89031 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0364-2022 |
| Event ID | 89031 |
| Event Description | smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA. |
| Quantity | 35 units |
| Recall Reason | Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent s reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System. |
| Device Classification | 20211222 |
| Device Code Info | Batch Number: 20HM10255, 20HM10256, 20HM10257, UDI |
| Center Classification Date | 20211210 |
| Recall Initiation Date | 20211101 |
| Recalling Firm | Smith & Nephew, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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