SELF CENTERING 2055-58-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295084754), received between Jan 27, 2020 and Sep 5, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT IN ORDER TO DO A TRIAL HIP REPOSITION IN A CATHCART PROCEDURE YOU HAVE TO PUT A TRIAL SPACER IN A CATHCART TRIAL HEAD. IT SEEMED IMPOSSIBLE TO PUT THIS TRIAL SPACER IN A 58MM AND A 60MM HEAD. OTHER HEADS SHOWED NO PROBLEMS. NO DAMAGE. SPACER DIDN¿T FIT IN TRIAL HEAD, ANOTHER INSTRUMENT SET WAS USED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977029 ↗
• 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 20441867 ↗
• 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 20439283 ↗
• 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 20302625 ↗
• MalfunctionSep 26, 2023Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  INSTRUMENTS HAVE BECOME DAMAGED. WRITING FOR THE TRIAL SIZE HAS RUBBED OFF. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON (B)(6) 2023 STATED: B. PLEASE PROVIDE THE LOT NO. OF THE REPORTED DEVICES. -LOT NUMBERS CANNOT BE READ AS THEY HAVE WORN OFF OF THE DEVICES, THERE IS 3 OF EACH INSTRUMENT. C. PLEASE CONFIRM THE DATE OF EVENT, IT HAS BEEN ADDED AS PER THE SOURCE FILE. - (B)(6) 2023. D. WHAT IS THE ALERT DATE OF THE COMPLAINT? WHEN WERE YOU MADE AWARE OF THE EVENT? - (B)(6) 2023. E. PLEASE CLARIFY WHAT DOES IT MEAN WITH "INSTRUMENTS HAVE BECOME DAMAGED." THE WRITING ON THE SIDE OF THE TRIALS, WHICH THE SURGEONS NEEDS TO READ TO BE ABLE TO DECIDE WHICH FINAL IMPLANT TO USE IS NO LONGER READABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818266 ↗
• MalfunctionOct 4, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE 58 TRIAL WAS MIS-SHAPED AND SPACER TRIALS AND THE HANDLE WOULD NOT FIT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536999 ↗
• MalfunctionJun 24, 2022Material Integrity Problem; Material Integrity Problem

  DAMAGED INSTRUMENTS IDENTIFIED BY CSSD. NO SURGEON WAS ASSOCIATED WITH THIS EVENT. SURGERY WAS NOT DELAYED. INSTRUMENTS HAVE BEEN TAGGED OUT AND READY FOR COLLECTION BY COURIER. NO FRAGMENTS WERE GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14798936 ↗
• 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 14338348 ↗
• MalfunctionJan 27, 2020Crack; Crack

  IT WAS REPORTED THAT THE SIZE 58MM ENDOMOD HEAD WAS CRACKED, ALL PIECES REMOVED FROM PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9633388 ↗