HEALIX ADVANCE PERMACORD 223133Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705024681), received between Mar 25, 2020 and Jun 6, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A JOINT LIP ARTHROPLASTY FOR GLENOID FOSSA FRACTURE OF THE RIGHT SHOULDER SURGICAL PROCEDURE THE 6.5 HEALIXADV BR3SUTANC PCORD DEVICE WHEN THE DEVICE WAS INSERTED, THE IMPLANT PART BROKE OFF. THERE WERE NO BROKEN PIECES IN THE BODY. ANOTHER ANCHOR WAS USED FOR SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477996 ↗
• MalfunctionMar 25, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA PERSONAL INTERACTION THAT THE 6.5 HEALIXADV BR3SUTANC PCORD CAME OFF THE ANCHOR DURING SUTURE LIGATION, IN ADDITION THE 4.5 HEALIXADV BR3SUTANC PCORD SUTURE CAME OFF THE ANCHOR AGAIN. NO PATIENT CONSEQUENCES, THERE WAS A DELAY OF 30 MINUTES REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9881202 ↗

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