Recall Z-0365-2022— Smith & Nephew, Inc.

Name: FDA recall Z-0365-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-01

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2021-11-01. It names one FDA 510(k) clearance: K201918. Product: smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102. 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..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-11-01
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K201918 — EVOS Large Fragment Plating SystemSmith & Nephew, Inc.·cleared 2020-11-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.