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

smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM… — recall Z-0366-2022

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

As described by U.S. FDA — Device Enforcement: smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0366-2022
Date of alert
2021-11-01
Country / jurisdiction
United States
Risk level
Class II
Notice type
recall
Brand
Smith & Nephew, Inc.
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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