FDA Device recall Z-0364-2022
smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
- 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, R, 5H, 90MM, REF 72573201 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-0364-2022 |
| 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, R, 5H, 90MM, REF 72573201
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: 20HM10255, 20HM10256, 20HM10257, UDI |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Smith And Nephew
- TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
FDA Device · Class II · 2026-06-24 · Smith And Nephew - BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener
FDA Device · Class II · 2025-12-24 · Smith And Nephew - META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
FDA Device · Class II · 2025-05-28 · Smith And Nephew - BIORAPTOR Suture Anchors
FDA Device · Class II · 2024-12-11 · Smith And Nephew - Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar co…
FDA Device · Class II · 2024-11-13 · Smith And Nephew
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0364-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.