EVOS 72441014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556640265), received between Aug 9, 2024 and Aug 9, 2024 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K162078, K170887, 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.

• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A TIBIAL ORIF PROCEDURE PERFORMED BEFORE (B)(6) 2020 TO REDUCE A TRANSVERSE TIBIAL SHAFT FRACTURE, ONE (1) PATIENT DEVELOPED AN INFECTION AND ATROPHIC NONUNION OF THE FRACTURE. ANY ADDITIONAL MEASURES TAKEN TO ADDRESS THIS OUTCOME WERE NOT COMMUNICATED. NO EVIDENCE OF RADIOGRAPHIC UNION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 19950576 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162078, K170887, 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.