EVOS 71175057Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556636565), received between Apr 15, 2021 and Apr 15, 2021 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K162078); 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.

• MalfunctionApr 15, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING PROCEDURE IT WAS NOTICED THAT THE THREADS ON THE 3.5 LOCKING SCREW GUIDE HAVE WORN OUT. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671374 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162078. 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.