Formula 0375951112Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327054866), received between Oct 11, 2023 and Oct 11, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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. How this data works · Data updated Oct 13, 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 11, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE SHAVER BLADE DETACHED DURING SURGERY AND WAS NOT NOTICED. A SECOND SURGERY WAS THEN PERFORMED WHERE THE DETACHED PIECE WAS DISCOVERED AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916516 ↗