ACTIS 2011-01-260Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295495710), received between Feb 5, 2021 and Jul 19, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K150862); 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.

• MalfunctionJul 19, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT REAMERS WERE DULL. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17351028 ↗
• MalfunctionFeb 5, 2021Break; Failure to Cut; Break; Failure to Cut

  SURGEON NOTICED THE PROBLEM ON ACTIS REAMER STABILIT AND SAW THE RISK OF THE BROKEN REAMER DURING SURGERY. THICKNESS OF THE REAMER BODY SEAMS ARE TOO WEAK EVEN THOUGH NO EVENT HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11289540 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150862. One submission often covers many models, so check the product and lot details in each record.

• Z-0650-2017 · Oct 25, 2016 · Terminated
  ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with labe