EVOS 72573202Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556753026), received between Aug 9, 2023 and Aug 9, 2023 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (K201918, K213126); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER INTERNAL FIXATION SURGERY WAS PERFORMED ON AN UNKNOWN DATE, IT WAS IDENTIFIED THAT AN EVOS 3.5MM CONDYLAR MEDIAL DISTAL FEMUR PLATE R 115MM 5H WAS NOT EFFECTIVE IN MAINTAINING REDUCTION. IT IS UNKNOWN HOW THIS EVENT WAS TREATED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 17495465 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201918, K213126. One submission often covers many models, so check the product and lot details in each record.

• Z-0363-2022 · Nov 1, 2021 · Terminated
  smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
• Z-0364-2022 · Nov 1, 2021 · Terminated
  smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
• Z-0366-2022 · Nov 1, 2021 · Terminated
  smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
• Z-0365-2022 · Nov 1, 2021 · Terminated
  smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102