EVOS 72562010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556752531), received between Jun 28, 2024 and Jun 28, 2024 — 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.

• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT VISITED EMERGENCY DEPARTMENT DUE TO PEDESTRIAN VS. CAR ACCIDENT, RT FEMUR FRACTURE, LEFT HUMERAL FRACTURE, LEFT ANKLE FRACTURE, LEFT GREAT TOE FRACTURE, LEFT KNEE LIGAMENT INJURY, MULTIPLE DISRUPTIONS PELVIC RING WITH UNSTABLE PATTERN. THIS PATIENT UNDERWENT AN ORIF FIXATION WITH EVOS PLATE AND SCREWS. THE PATIENT UNDERWENT REVISION SURGERY 17 DAYS AFTER PRIMARY PROCEDURE DUE TO A FAILURE OF THE LEFT ORIF HUMERUS FIXATION. DURING THE REVISION, THE PLATE AND SCREWS WERE EXPLANTED AND A NEW EVOS SYSTEM WAS IMPLANTED INSTEAD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19638569 ↗

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