HEALIX ADVANCE PERMACORD 223134Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705024674), received between Mar 11, 2026 and Apr 3, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K073412, K100012, K133794); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Crack

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SURGEON EXPERIENCED THE HEALIX ADVANCE PERMACORD SUTURE DEVICE BREAKING AND FRAYING INTRAOPERATIVELY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780114 ↗
• MalfunctionApr 3, 2026Crack

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SURGEON EXPERIENCED THE HEALIX ADVANCE PERMACORD SUTURE DEVICE BREAKING AND FRAYING INTRAOPERATIVELY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780113 ↗
• MalfunctionMar 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, AFTER PREPARING THE PILOT HOLE IN THE HUMERAL HEAD, A 4.5 HEALIXADV PEEK ANC PCORD ANCHOR WAS INSERTED ACCORDING TO STANDARD TECHNIQUE. UPON INSERTION, THE ANCHOR FAILED TO MAINTAIN SUTURE INTEGRITY. THE SUTURES BECAME DETACHED FROM THE BOTTOM OF THE ANCHOR, INDICATING A FAILURE OF THE INTERNAL SUTURE-RETENTION MECHANISM. NO EXTERNAL DEFORMITIES, CRACKS, OR MATERIAL DEFECTS WERE NOTED ON THE OUTSIDE OF THE ANCHOR UPON INSPECTION. THE APPEARANCE SUGGESTED THAT THE INTERNAL BRIDGE OR INTERNAL SUTURE-RETENTION COMPONENT MAY HAVE FAILED. THE ANCHOR WAS SUBSEQUENTLY DISCARDED AND WAS NOT AVAILABLE FOR RETURN OR FURTHER ANALYSIS. NO PATIENT INJURY WAS REPORTED, AND AN ALTERNATIVE FIXATION METHOD WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568079 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073412, K100012, K133794. One submission often covers many models, so check the product and lot details in each record.

• Z-2208-2011 · Feb 24, 2011 · Terminated
  DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD Product Code: 210811 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Bic