HEALIX KNOTLESS 222288Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705020409), received between Sep 10, 2025 and Sep 10, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 18, 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.

• MalfunctionSep 10, 2025Migration; Migration

  IT WAS REPORTED THAT AT THE BEGINNING OF AN UNSPECIFIED SURGICAL PROCEDURE, THE SUTURES ARE PLACED IN THE BICEPS WHICH ARE FIXED TO THE HUMERUS BY MEANS OF A KNOTLESS 4.75 HEALIX ADVANCE KNTLS PEEK ANCHOR DEVICE WHICH BEGINS WITH ITS RESPECTIVE PURPLE INITIATOR. THE DEVICE BEGINS TO LOWER THE ANCHOR DEVICE BUT THERE IS A LOT OF TENSION OF THE TISSUE AND OPENS THE TIP OF THE ANCHOR PREVENTING IT TO HOLD INSIDE THE BONE. THE ANCHOR DEVICE WAS EXPELLED FROM THE BONE MAKING IT NECESSARY TO PASS A SECOND KNOTLESS SUTURE. A SELF-DRILLING 4.9 HEALIX ADV SP PEEK CE DEVICE IS PASSED, WHICH REMAINED PROPERLY IN THE BONE. THE PROCEDURE CONTINUED WITH A SUTURE OF THE ROTATOR CUFF, WITH A 5.5HLX ADV PK ANC-DYNA 3-SUT DEVICE. THE ANCHOR WAS SCREWED INTO THE BONE, AND THE SUTURES WERE STARTED IN THE CUFF. IT WAS OBSERVED THAT THE ANCHOR WAS EXPELLED FROM THE BONE AND REMAINED ON THE OUTSIDE. THE DOCTOR REQUESTED A SECOND ANCHOR OF THE SAME SIZE, WHICH WAS PLACED IN A DIFFERENT POSITION IN THE BONE, AND FUNCTIONED PROPERLY. AT THE END OF THE PROCEDURE, THE SUTURES WERE CUT AND IT WAS OBSERVED THAT THE PREVIOUSLY INSERTED KNOTLESS SP ANCHOR, HAD ALSO BEEN EXPELLED FROM THE BONE. IT WAS NOT REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020118 ↗