EVOS 72442460Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556440094), received between Dec 12, 2022 and Dec 12, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryDec 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, ONE (1) EVOS 2.4MM FLEX PLATE 6 HOLE DEVICE WAS USED ON THE INFERIOR ASPECT. THE EVOS 2.4MM FLEX PLATE 6 HOLE DEVICE BENT IN PLANE TO FIT DISTAL ASPECT OF THE CLAVICLE AND SUPERIOR END, A SLIGHT SAGITTAL BEND WAS APPLIED WITH A SYNTHES CMF PLATE BENDER. ABOUT THE THIRD HOLE FROM THE END, THE PLATE FRACTURED AT THE SCREW HOLE. PLATE HAD TO BE USED SINCE THERE WAS NO SPARE IMPLANT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15961707 ↗

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