EVOS 72403550NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556638125), received between Aug 9, 2024 and Aug 9, 2024 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K162078, K172262, 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, 2024Fracture; Fracture

  IT WAS REPORTED THAT, FOLLOWING AN TIBIA AND FIBULA ORIF PROCEDURE PERFORMED BEFORE OCTOBER 2020 TO REDUCE A LATERAL SPLIT DEPRESSION PLATEAU FRACTURE AND A LATERAL MALLEOLUS FRACTURE, ONE (1) PATIENT SUSTAINED THE BREAKAGE OF ONE SYNDESMOSIS SCREW THAT WAS SUBSEQUENTLY EXPLANTED. THESE FRACTURES WERE REPORTEDLY REDUCED AT TWELVE (12) POSTOPERATIVE WEEKS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19950845 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162078, K172262, 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.