SELF CENTERING 2057-40-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295084822), received between Jun 28, 2023 and Jun 28, 2023 — classified as 1 malfunction.

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 16, 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.

• MalfunctionJun 28, 2023Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PRODUCT IN QUESTION WAS USED IN THE SURGERY VIA BIP. IN THE SURGERY, DURING THE BIPOLAR CUP SIZING TRIAL, NUMEROUS GREEN PIECES WERE FOUND INSIDE THE BODY. THE SURGEON WIPED THEM WITH GAUZE AND IDENTIFIED THEM AS PIECES FROM THE PRODUCT. HE OR SHE TOOK THE PIECES THAT COULD BE VISUALLY REMOVED, WIPED THE SOFT TISSUE SURFACE WITH GAUZE, AND PERFORMED A PULSE WASH. FOR THE FINAL TRIAL, 39 MM (A 1 MM UNDERSIZE) WAS USED. IT IS ASSUMED THAT THE SURFACE AND LIMBUS FAILED WHEN RUBBING AGAINST THE OSTEOTOMIZED NECK. PULSE CLEANING WAS PERFORMED BEFORE AND AFTER IMPLANTATION, BUT SOME PIECES STILL APPEARED. THE SURGEON REMOVED THE PIECES AS MUCH AS POSSIBLE AND CLOSED THE WOUND. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 17219329 ↗