Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0363-2022 — smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101

U.S. FDA — Device Enforcement · United States · 2021-11-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0363-2022
Date of alert
2021-11-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smith & Nephew, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00885556752999
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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