Centrax 6226-2-641Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327032147), received between May 1, 2017 and Dec 23, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 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.

• MalfunctionDec 23, 2021Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  ONE OF THE CENTRAX LOCKING RINGS LIFTED UP A LITTLE AFTER LOCKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13079125 ↗
• MalfunctionDec 20, 2018Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING A BHA, A V40 HEAD COULD NOT SLIDE SMOOTHLY IN THE CENTRAX (41 MM). ANOTHER CENTRAX (42 MM) WAS USED INSTEAD WITHOUT ANY REPORTED PROBLEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8186512 ↗
• MalfunctionJul 16, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING A BHA, THE SURGEON FELT THE CENTRAX COULD NOT SLIDE SMOOTHLY ON THE V40 HEAD. IT WAS LIKE A TIGHTNESS , HIGH SLIDING FRICTION BETWEEN HEAD AND CENTRAX. THE CENTRAX WAS USED AS IS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7691805 ↗
• MalfunctionJul 2, 2018Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT, DURING A BHA, THE SURGEON FELT THE SLIDING MOTION WAS NOT SMOOTH ON THE V40 HEAD. HOWEVER, HE IMPLANTED IT AS IS BECAUSE OF NO SPARE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7656362 ↗
• MalfunctionDec 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A BIPOLAR HIP ARTHROPLASTY, THE V40 HEAD DID NOT SLIDE SMOOTHLY ON THE INSERT OF THE CENTRAX. THE SURGEON IMPLANTED THE DEVICES AS IS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7152361 ↗
• MalfunctionDec 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BIPOLAR AND HEAD DID NOT MOVE SMOOTHLY. THE PHYSICIAN CHANGED THE BIPOLAR AND HEAD AND COMPLETED THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7129914 ↗
• MalfunctionNov 28, 2017Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A BHA, THE V40 DID NOT SLIDE SMOOTHLY ON THE INSERT OF THE CENTRAX. A SPARE HEAD AND CENTRAX WERE USED INSTEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7063146 ↗
• MalfunctionSep 18, 2017Device Operates Differently Than Expected; Scratched Material; Insufficient Device Problem Information; Device Operates Differently Than Expected; Scratched Material; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A BHA, THE CENTRAX COULD NOT SLIDE SMOOTHLY ON THE V40 HEAD. THEREFORE, A SPARE CENTRAX WAS USED INSTEAD WITH THE V40.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6873698 ↗
• MalfunctionMay 1, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT, DURING A BHA, THE CENTRAX DID NOT SLIDE SMOOTHLY ON THE HEAD. A SPARE CENTRAX WAS USED INSTEAD.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6533637 ↗