EVOS 72440806Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556640036), received between Aug 16, 2021 and Aug 16, 2021 — classified as 2 injuries.

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.

• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A 19 MONTHS FOLLOW UP AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTED METALWORK, INFECTED FRAME AND EVENTUAL ANKLE FUSION. PRIMARY FRACTURE FIXATION SURGERY WAS PERFORMED DUE TO A FIBULA FRACTURE. THIS INFORMATION WAS COLLECTED FROM A POST-MARKET DATA COLLECTION ACTIVITY. THE DATA IS ANONYMIZED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Unspecified Infection

  MAUDE report 12329291 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A 13 MONTHS FOLLOW UP AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED, THE PATIENT UNDERWENT REVISION SURGERY DUE TO GENERALIZED PAIN. PRIMARY FRACTURE FIXATION SURGERY WAS PERFORMED DUE TO A FIBULA FRACTURE. THIS INFORMATION WAS COLLECTED FROM A POST-MARKET DATA COLLECTION ACTIVITY. THE DATA IS ANONYMIZED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 12329278 ↗

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.