SELF CENTERING 2055-55-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295084723), received between May 9, 2022 and Nov 21, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2024Crack; Crack

  IT WAS REPORTED, THAT WHILE REMOVING BIPOLAR HEAD TRIAL FROM HANDLE. THE HEAD CRACKED.

  Patient problems: Insufficient Information

  MAUDE report 20748310 ↗
• MalfunctionOct 14, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT HEAD TRIALS DID NOT FIT ON TRIAL STICK AND SIZES ARE NOT VISIBLE. THESE WERE FOUND AFTER THE CASE SO THERE WERE NO ADVERSE CONSEQUENCES AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441493 ↗
• MalfunctionOct 14, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT THE HEAD TRIALS DO NOT FIT ONTO TRIAL STICK. THE SIZES ARE NOT VISIBLE ON THE HEAD TRIALS. THESE WERE FOUND AFTER THE CASE SO THERE WERE NO ADVERSE CONSEQUENCES AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439291 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE ROD ENDO HEAD TRIALS WERE GETTING OLD AND DO NOT FIT ON THE TRIAL STICK. THESE WERE FOUND AFTER THE CASE SO THERE WAS NO SURGICAL DELAY AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302529 ↗
• MalfunctionAug 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THERE WAS SIGNIFICANT WEAR ON MOD-ENDO TRIAL HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19908370 ↗
• MalfunctionMay 9, 2022Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THE SIZING INFORMATION WORN OFF TRIALS DUE TO MULTIPLE AUTOCLAVING/ USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338232 ↗