SELF CENTERING 2055-61-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295084785), received between May 9, 2022 and Jan 27, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MOD ENDO BIPOLAR HEAD TRIALS LOST POST OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186998 ↗
• MalfunctionApr 1, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE BP HEAD TRIALS ARE SCRATCHED AND THE METAL ON THE INSTRUMENTS ARE PITTED. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21741250 ↗
• MalfunctionOct 14, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: THERE WAS NO SURGICAL DELAY AND THE LOT NUMBERS WERE NOT VISIBLE ON THE HEAD TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441360 ↗
• MalfunctionOct 14, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE ALLEGATION WAS THAT THE SIZES WERE NOT VISIBLE ON THE HEAD TRIALS. THERE WAS NO SURGICAL DELAY AND THE LOT NUMBERS ARE NOT VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438959 ↗
• 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 20302615 ↗
• MalfunctionMay 5, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT TRIAL IS SCUFFED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16878611 ↗
• MalfunctionMar 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT IT WAS AN ACCIDENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16487757 ↗
• MalfunctionMar 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED. AND STATED, THAT IT WAS AN ACCIDENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16487718 ↗
• 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 14338426 ↗