Centrax 6226-2-652Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327032253), received between Dec 22, 2017 and Jul 21, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A BHA, THERE WAS A GAP BETWEEN A 52MM SHELL AND A LOCKING RING. THEREFORE, A SURGEON DECIDED TO USED 51MM BUT IT WAS ALSO SAME CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10300925 ↗
• MalfunctionDec 4, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT, DURING A BHA, A SURGEON NOTICED A DEFORMED PE TAB (ONE OUT OF EVERY EIGHT). IT WAS USED AS IS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9411693 ↗
• MalfunctionJul 4, 2019Misassembled; Misassembled

  IT WAS REPORTED THAT, DURING A SURGERY, THE LOCKING RING WAS NOT ASSEMBLED INTO THE SHELL. A SPARE WAS USED INSTEAD. UPDATE: "AFTER REMOVED THE C-CLIP, THE LOCKING RING WAS NOT FULLY SEATED IN THE SHELL." RIGHT SIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8762680 ↗
• MalfunctionJun 11, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE PROCEDURE, LOCKING RING WAS NOT ASSEMBLED INTO BIPOLAR AND THE SURGEON TRIED SOME TIMES BUT LOCKING RING WAS NOT ASSEMBLED. THE BIPOLAR CUP WAS CHANGES TO ONE SIZE BIGGER ONE AND THE PROBLEM WAS SOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8687189 ↗
• MalfunctionJul 23, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT, DURING A BHA, A SURGEON FOUND A DEFORMED INSERT IN THE SHELL. A SPARE WAS USED INSTEAD. AS PER ADDITIONAL INFORMATION RECEIVED; ONE OF THE 8 TABS OF INSERT WAS SHIFTED TOWARD THE CENTER. IT WAS NOTICED WHEN THE SURGEON WAS TRYING TO COMBINE IT WITH THE HEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7711976 ↗
• MalfunctionApr 9, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE V40 HEAD WAS NOT LOCKED TO THE CENTRAX CUP. THEREFORE, THE CUP AND HEAD WERE CHANGED TO NEW DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7409731 ↗
• MalfunctionMar 26, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT COULDN'T LOCKED BETWEEN THE CENTRAX 52MM CUP AND RING. SO 53MM CUP WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7370260 ↗
• MalfunctionDec 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT, DURING A BHA, THE LOCKING RING WAS NOT LOCKED DUE TO TIGHTNESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7142458 ↗