EVOS 72413544Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556637074), received between Oct 12, 2020 and Oct 12, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 12, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE EVOS 3.5MM X 44MM LCK SCR S-T PACKAGE WAS LABELED AS A 44 MM BUT THE ACTUAL MEASURE IS 34 MM, THE EVOS 3.5MM X 42MM LCK SCR S-T PACKAGE WAS LABELED AS A 42 MM BUT THE ACTUAL MEASURE IS 28 MM AND THE EVOS 3.5MM X 24MM CTX SCR S-T PACKAGE WAS LABELED AS A 24 MM BUT THE ACTUAL MEASURE IS 30 MM. THE ACTION TAKEN WAS TO RE-MEASURED SCREWS BEFORE HANDING TO SURGEON BEFORE INSERTION, SO SURGEON REMOVED THE ABOVE SCREWS AND DRILLED AGAIN DUE TO ADJUSTMENT WITH PLATES. SCREWS WERE MEASURED DIFFERENTLY TO ABOVE, HENCE USED DIFFERENT LENGTH EVOS SCREWS. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10667799 ↗

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.