EVOS 72413530Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556636961), received between Nov 30, 2025 and Nov 30, 2025 — classified as 2 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K162078, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2025Migration; Migration

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A FAILED PLATE SCREW CONSTRUCT. ONE (1) EVOS 3.5MM X 30MM LCK SCR S-T CAME OUT OF ITS POSITION. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS RESOLVED. THE CURRENT HEALTH STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23677334 ↗
• InjuryNov 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A FAILED PLATE SCREW CONSTRUCT. ONE (1) EVOS 3.5MM X 30MM LCK SCR S-T WAS FRACTURED. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS RESOLVED. THE CURRENT HEALTH STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23677333 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162078, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.

• Z-0265-2022 · Oct 25, 2021 · Open, Classified
  Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.