EVOS 72402010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556424896), received between Mar 16, 2023 and Mar 16, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K140814, K210837, 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.

• InjuryMar 16, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE SURGEON WAS USING EVOS SCREWS TO REDUCE AN OSTEOTOMY SURGERY PERFORMED ON THE HALLUX OF THE PATIENT´S LEFT FOOT (1 TOE). THE SURGEON WAS ATTEMPTING TO USE THE SCREWS ALONE, WITHOUT THE PLATE. AS REPORTED, WHEN TRYING TO INSERT THE SCREWS, THEY WOULD NOT REDUCE THE FRACTURE ADEQUATELY. WHEN TRYING TO REPOSITION ONE OF THE SCREWS, A BONE FRAGMENT BROKE. AFTER THIS, THE SURGEON TRIED TO USE A PLATE, AND WAS UNSUCCESSFUL. AT THE END, THE SURGEON FIXATED THE BONE USING BLOCKING SCREWS AND THE PROCEDURE WAS FINISHED. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 16558918 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140814, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.

• Z-2945-2020 · Aug 24, 2020 · Terminated
  EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and s
• Z-0408-2018 · Nov 29, 2017 · Terminated
  smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from