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ORTHOCORD HEALIX BR 222229Recalls & reported problems

Medos International Sàrl · HEALIX BR Anchor w/ORTHOCORD TCP/PLGA Absorbable Anchor (1) Violet (1) Blue Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm) 4.5mm · Class 2 · Implant

All models of ORTHOCORD HEALIX BR (5)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Medos Healix BR suture anchor, used in shoulder repair, has 118 adverse event reports, with 5 injuries and no deaths. Most describe the anchor breaking off during surgery. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
118
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 10886705007769), received between Jun 18, 2018 and Jan 27, 2026 — classified as 5 injuries, 113 malfunctions.

The most frequently reported specific device problem is “Break” (105 reports).

6 other recalls cover devices cleared under the same FDA submission (K073412, K150209); 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.

Reports received per month

Nov 2023: 5 reportsDec 2023: 4 reportsJan 2024: 8 reportsFeb 2024: 0 reportsMar 2024: 3 reportsApr 2024: 9 reportsMay 2024: 2 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 2 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520269
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break105
  • Material Frayed4
  • Device Damaged Prior to Use3
  • Loose or Intermittent Connection3
  • Adverse Event Without Identified Device or Use Problem2
  • Material Deformation2
  • Crack1
  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions86
  • No Consequences Or Impact To Patient29
  • Foreign Body In Patient5
  • Fluid Discharge1
  • Impaired Healing1
  • Not Applicable1
  • Purulent Discharge1
  • Unspecified Infection1

Recent adverse event reports

The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 27, 2026Break

    IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE 4.5 HEALIX BR ANCHOR W/OCORD WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24189287 ↗
  • MalfunctionJul 17, 2025Break; Break

    IT WAS REPORTED THAT DURING AN ACROMIOPLASTY AND LABRAL INJURY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE BROKE AT THE MOMENT OF IMPLANTATION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22536407 ↗
  • MalfunctionNov 19, 2024Break; Break

    IT WAS REPORTED THAT DURING A LEFT ARTHROSCOPIC SHOULDER JOINT CLEANING SURGERY AND ROTATOR CUFF REPAIR SURGICAL PROCEDURE 2X 4.5 HEALIX BR ANCHOR W/OCORD DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER DEVICE AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20724403 ↗
  • MalfunctionNov 19, 2024Break; Break

    IT WAS REPORTED THAT DURING A LEFT ARTHROSCOPIC SHOULDER JOINT CLEANING SURGERY AND ROTATOR CUFF REPAIR SURGICAL PROCEDURE 2X 4.5 HEALIX BR ANCHOR W/OCORD DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER DEVICE AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20724239 ↗
  • MalfunctionAug 26, 2024Break; Break

    THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE HAD BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED, AND ANOTHER DEVICE WAS USED TO CONTINUE THE SURGERY. HOWEVER, THE SAME ISSUE OCCURRED WITH THE REPLACEMENT DEVICE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20069729 ↗
  • MalfunctionMay 22, 2024Break; Break

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19372441 ↗
  • MalfunctionMay 22, 2024Break; Break

    IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19369701 ↗
  • MalfunctionApr 25, 2024Break; Break

    IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE BROKE OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19184883 ↗
  • MalfunctionApr 24, 2024Break; Break

    THIS IS REPORT 2 OF 2 FOR (B)(4) . IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE BROKE. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19176730 ↗
  • MalfunctionApr 24, 2024Break; Break

    THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED FROM (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE BROKE. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19176722 ↗
  • MalfunctionApr 10, 2024Break; Break

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2 024, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19077810 ↗
  • MalfunctionApr 4, 2024Break; Material Frayed; Device Damaged Prior to Use; Break; Material Frayed; Device Damaged Prior to Use

    IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE WAS BROKEN UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SUTURE WAS FRAYED AND BROKEN ON THE DEVICE. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19042181 ↗
  • MalfunctionApr 4, 2024Break; Break

    REPORT 1 OF 2 FOR (B)(4) IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT THE 4.5 HEALIX BR ANCHOR W/OCORD ANCHOR DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19039499 ↗
  • MalfunctionApr 4, 2024Break; Break

    REPORT 2 OF 2 FOR (B)(4) IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT THE 4.5 HEALIX BR ANCHOR W/OCORD ANCHOR DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19039497 ↗
  • MalfunctionApr 3, 2024Break; Break

    IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19035765 ↗
  • MalfunctionApr 3, 2024Break; Break

    IT WAS REPORTED FROM CHINA THAT DURING A ARTHROSCOPIC SHOULDER STABILIZATION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX BR ANCHOR W/OCORD ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19032158 ↗
  • MalfunctionMar 25, 2024Break; Break

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE THE TWO (X2)4.5 HEALIX BR ANCHOR W/OCORD DEVICES WERE BEING USED WHEN IT WAS REPORTED THAT THE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18970495 ↗
  • MalfunctionMar 25, 2024Break; Break

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE TWO (X2) 4.5 HEALIX BR ANCHOR W/OCORD DEVICES WERE BEING USED WHEN IT WAS REPORTED THAT THE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18970491 ↗
  • MalfunctionMar 7, 2024Break; Break

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18855396 ↗
  • MalfunctionJan 25, 2024Break; Break

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE SUTURE ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE WAS BROKEN OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18579781 ↗
  • MalfunctionJan 19, 2024Break; Break

    IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE ANCHOR WAS BROKEN. ALL BROKEN PARTS WERE REMOVED. HE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18547572 ↗
  • MalfunctionJan 19, 2024Break; Break

    IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE ANCHOR WAS BROKEN. ALL BROKEN PARTS WERE REMOVED. HE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18547525 ↗
  • MalfunctionJan 17, 2024Break; Material Frayed; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Break; Material Frayed; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT BEFORE A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2023, IT WAS OBSERVED THAT THE PACKING (DID NOT USE) WAS OPENED AND IT WAS NOTED THAT THE HEALIX BR ANCHOR W/ORTHOCORD DEVICE WAS BROKEN OFF. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SUTURE WAS DAMAGED - FRAYED, AND THE DEVICE WAS FRACTURED AND HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18525383 ↗
  • MalfunctionJan 4, 2024Break; Break

    IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023 THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE WAS BROKEN OFF. CHANGED TO ANOTHER 4.5 HEALIX BR ANCHOR W/OCORD DEVICE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18445214 ↗
  • MalfunctionJan 4, 2024Break; Break

    IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023 THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE WAS BROKEN OFF. CHANGED TO ANOTHER 4.5 HEALIX BR ANCHOR W/OCORD DEVICE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18445178 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073412, K150209. One submission often covers many models, so check the product and lot details in each record.

  • Z-1680-2023 · Apr 13, 2023 · Open, Classified
    DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
  • Z-1678-2023 · Apr 13, 2023 · Open, Classified
    DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
  • Z-1677-2023 · Apr 13, 2023 · Open, Classified
    DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
  • Z-1681-2023 · Apr 13, 2023 · Open, Classified
    DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
  • Z-1679-2023 · Apr 13, 2023 · Open, Classified
    DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
  • 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

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Sources and updates

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