HEALIX ADVANCE PERMACORD 223130Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705024810), received between Sep 6, 2024 and Sep 6, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF SURGICAL PROCEDURE IT WAS OBSERVED THAT THREE 5.5 HEALIXADV BR ANC PCORD ANCHOR DEVICES BROKE HALF-WAY DURING DEPLOYMENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158463 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF SURGICAL PROCEDURE IT WAS OBSERVED THAT THREE 5.5 HEALIXADV BR ANC PCORD ANCHOR DEVICES BROKE HALF-WAY DURING DEPLOYMENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 3 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158410 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF SURGICAL PROCEDURE IT WAS OBSERVED THAT THREE 5.5 HEALIXADV BR ANC PCORD ANCHOR DEVICES BROKE HALF-WAY DURING DEPLOYMENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 3 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158259 ↗

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