Centrax 6226-2-650Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327032239), received between Jun 6, 2018 and Mar 29, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2022Difficult to Insert; Failure to Advance; Difficult to Insert; Failure to Advance

  DURING BHA, THE HEAD MOVEMENT WITHIN THE CENTRAX IS STIFF AND DOES NOT TURN PROPERLY, UNLIKE USUAL. HE MADE SEVERAL ATTEMPTS TO LOCK THE LOCKING RING. THE RING MIGHT BE DEFORMED DUE TO IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13937997 ↗
• MalfunctionApr 13, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT, DURING A BHA THE LOCKING RING WAS NOT PROPERLY LOCK WITH A SHELL, A SURGEON CHECKED AND NOTICED A DEFORMED PE OF SHELL. A SPARE CENTRAX WAS USED ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9954271 ↗
• InjuryMar 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON AN UNKNOWN DATE, THE PATIENT UNDERWENT BHA PROCEDURE. ON UNKNOWN DATE AFTER BHA THE BIPOLAR CUP WAS DISLOCATED, AND ON (B)(6) 2020, "TTHE" REVISION WAS PERFORMED (THE BIPOLAR CAP AND THE INNER HEAD WERE REVISED). THE REPORTING SURGEON¿S OPINION: IT WAS FIRST CASE THAT ONLY THE BIPOLAR CAP WAS DISLOCATED. THERE WAS A POSSIBILITY THAT LOCKING HAD NOT BEEN DONE PROPERLY AT THE INITIAL BHA. BUT THE CAUSE WAS UNKNOWN. THE REPORTING SR¿S OPINION: THE INNER POLYETHYLENE OF THE BIPOLAR CAP WAS FOUND TO BE DEFORMED AFTER THE REMOVAL. IT WAS UNKNOWN IF THIS WAS THE CAUSE OF THE EVENT. BUT PLEASE INVESTIGATE WHY IT WAS DEFORMED AND THE CAUSE OF DISLOCATION.

  Patient problems: Injury

  MAUDE report 9834670 ↗
• MalfunctionJan 14, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A BHA, THE LOCKING RING WAS NOT LOCKED WITH THE SHELL. A CENTRAX (1 MM UNDER SIZE) WAS USED INSTEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245312 ↗
• MalfunctionOct 2, 2018Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  UNABLE TO LOCK THE RING WHILE REMOVING THE GREEN LOCKING RING AND USING THE CENTRANX FORCEPS TO ATTACH IT TO THE HEAD. AS A RESULT OF CONFIRMATION, A PART OF POLYETHYLENE WAS BROKEN. USED ANOTHER SIZE CUP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7926670 ↗
• MalfunctionJun 6, 2018Mechanical Problem; Mechanical Problem

  ATTEMPTED TO LOCK THE OUTER SHELL OF CENTRAX BY ATTACHING CENTRAX 'S LOCKING RING, BUT COULD NOT LOCK IT. ATTEMPTED TO REPLACE THE HEAD(SIZE CHANGE), WHEN TRYING TO REMOVE THE HEAD WHICH HAD ALREADY BEEN IMPLANTED, . BOTH THE STEM AND THE HEAD WERE REMOVED OUT OF THE PATIENT'S BODY. I REPLACED IT WITH A CEMENT STEM AND REPLACED THE HEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7573556 ↗