SPECIALIST SIGMA 96-6256Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295247555), received between Jul 25, 2023 and Apr 14, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionApr 14, 2026Material Deformation

  IT WAS REPORTED THAT THE SP*2 FEM NOTCH GUIDE SIZE 6 WAS FOUND TO HAVE A DEFORMED OR BENT TIP DURING INTRAOPERATIVE USE. THE EVENT DESCRIPTION INDICATED THAT THE CEMENT EXTRACTOR FOLDED THE TIP NEAR THE HANDLE, AND IF USED IN THIS MANNER, THE TIP COULD BREAK. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875373 ↗
• MalfunctionJul 25, 2023Break; Break

  IT WAS REPORTED THAT THE DOCTOR INSERTED THE RINGLET INTO THE FEMORAL HEAD. WHEN IT IS ATTEMPTED TO REMOVE THE HEAD, THE PIECE WAS DISASSEMBLED. THE PROCEDURE IS CARRIED OUT WITHOUT INCIDENT AND ENDS SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17388736 ↗