FDA Device recall Z-0363-2022
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
- FDA Device
- Class II
- terminated
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101 by Smith And Nephew, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0363-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-01 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
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.
Identifiers
| code_info | Batch Number: 20HM10249, 20HM10250, 20HM10251, 20HM22783, UDI (01) 00885556752999 (17) 310630 (10) 12345678 (11) 2210630 (21) 87654321 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0363-2022%22
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