EVOS 72413575Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556637159), received between Sep 9, 2021 and Sep 9, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING INSPECTION, (3) EVOS 3.5MM X 75MM LCK SCR S-T WERE FOUND TO BE INCORRECTLY PACKAGED, BECAUSE THE SCREWS ON THE PACKAGE WERE 70CM SCREWS AND NOT 75CM SCREWS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450200 ↗
• MalfunctionSep 9, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING INSPECTION, (3) EVOS 3.5MM X 75MM LCK SCR S-T WERE FOUND TO BE INCORRECTLY PACKAGED, BECAUSE THE SCREWS ON THE PACKAGE WERE 70CM SCREWS AND NOT 75CM SCREWS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450132 ↗
• MalfunctionSep 9, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING INSPECTION, (3) EVOS 3.5MM X 75MM LCK SCR S-T WERE FOUND TO BE INCORRECTLY PACKAGED, BECAUSE THE SCREWS ON THE PACKAGE WERE 70CM SCREWS AND NOT 75CM SCREWS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12448533 ↗

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.