HEALIX PEEK ORTHOCORD 222205Recalls & reported problems

Summary

The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 10886705007530), received between Nov 30, 2017 and Jun 2, 2026 — classified as 11 injuries, 175 malfunctions.

The most frequently reported specific device problem is “Break” (150 reports).

5 other recalls cover devices cleared under the same FDA submission (K071481, 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 186 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363224 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT DURING ACHILLES TENDON REPAIR SURGERY, THE HEALIX PEEK ORTHOCORD ANCHOR DEVICE 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 25279344 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD ANCHOR DEVICE BROKE. ALL BROKEN PIECES WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831022 ↗
• MalfunctionFeb 10, 2026Migration

  IT WAS REPORTED THAT DURING THE SURGERY, THE 4.5 HEALIX PEEK ANCH.W/OCORD PULLED OUT MULTIPLE TIMES. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A 5 MINUTE DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307786 ↗
• MalfunctionFeb 3, 2026Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250180 ↗
• MalfunctionJan 22, 2026Break; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE WAS FRACTURED (BROKEN IN TWO PIECES). IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE SHAFT WAS BROKEN OFF WHILE STILL IN THE PACKAGE PRIOR TO A ROTATOR CUFF REPAIR PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144419 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACHILLES REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE ANCHOR BROKE OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE 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 23908920 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. 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 23094735 ↗
• MalfunctionAug 19, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PATELLAR DISLOCATION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE THREADS PEELED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 22839736 ↗
• MalfunctionAug 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE ANCHOR WAS DEFORMED. THE ANCHOR WAS REMOVED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 22818474 ↗
• MalfunctionAug 14, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809114 ↗
• MalfunctionJul 22, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A PATELLAR DISLOCATION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE ANCHOR WAS PULED OUT DURING INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A TEN MINUTE 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 22565681 ↗
• MalfunctionJul 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PATELLAR DISLOCATION PROCEDURE, IT WAS FOUND THAT THE THREAD OF THE ANCHOR ON THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE PEELED WHEN THE ANCHOR WAS INSERTED. THERE WAS FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540320 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE ANCHOR 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 WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507703 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR RECONSTRUCTION OF A PATELLAR LIGAMENT IN THE KNEE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE ANCHOR WAS BROKEN OFF AND THE SUTURE WAS BROKEN. ALL BROKEN PARTS WERE REMOVED. THE USER CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY WHEN IMPLANTED IN PATIENT, THE SUTURE WAS BROKEN OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395799 ↗
• MalfunctionJul 3, 2025Break; Break

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPIC RECONSTRUCTION OF PATELLAR LIGAMENT PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. A REPLACEMENT DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. 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 WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394136 ↗
• MalfunctionJul 3, 2025Break; Break

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPIC RECONSTRUCTION OF PATELLAR LIGAMENT PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. A REPLACEMENT DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. 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 WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394135 ↗
• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE ANCHOR WAS BROKEN OFF. 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 22166415 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN UNKNOWN SURGERY USING THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE, THE PATIENT RETURNED TO THE OUTPATIENT CLINIC WITH POOR POSTOPERATIVE WOUND HEALING. IT WAS REPORTED THAT DURING THE OPERATION ON (B)(6) 2024, DUE TO MUSCLE STRENGTH IMBALANCE, THE TENDON WAS DISSECTED FROM THE MEDIAL END AND TRANSFERRED TO BALANCE MUSCLE STRENGTH, ANCHORING THE MUSCLE TO THE BONE USING ANCHORS. POSTOPERATIVE MUSCLE STRENGTH BALANCE, AND FOOT VARUS IMPROVEMENT WERE REPORTED. IT WAS REPORTED THAT THE IMPLANT WOUND HEALED WELL POSTOPERATIVELY WITHOUT ADVERSE EVENTS. IT WAS FURTHER REPORTED THAT ON (B)(6) 2024, THE PATIENT RETURNED TO THE OUTPATIENT CLINIC WITH POOR POSTOPERATIVE WOUND HEALING AND ON (B)(6) 2025, THE PATIENT WAS READMITTED FOR DEBRIDEMENT AND DRAINAGE WITH POOR POSTOPERATIVE WOUND HEALING. THE PATIENT IS CURRENTLY UNDER TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Impaired Healing

  MAUDE report 21512786 ↗
• MalfunctionFeb 19, 2025Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR WAS DEFORMED AND THE SUTURE WAS BROKEN ON THE DEVICE UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION OF THE PHOTO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE ANCHOR WAS FOUND BENT AT THE DISTAL TIP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413249 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. 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 21312948 ↗
• MalfunctionJan 31, 2025Break; Migration; Break; Migration

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD ANCHOR WAS BROKEN OFF. IT WAS REPORTED THAT ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. IT WAS FURTHER OBSERVE THAT THE ANCHOR PULLED OUT. 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 21286632 ↗
• MalfunctionDec 23, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE COULD NOT DETACH THE ANCHOR AND SHAFT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE OPTICAL DEVICE WAS STRIPPED/WORN/TWISTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. 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 21002791 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING A ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD ANCHOR DEVICE WAS BROKEN OFF, AND THE SUTURE DETACHED FROM THE ANCHOR. IT WAS REPORTED THAT ALL BROKEN PARTS OF THE DEVICE WERE REMOVED AND ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914809 ↗
• MalfunctionOct 22, 2024Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT DURING A LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. A REPLACEMENT DEVICE, 4.5 HEALIX ADVANCE BR W/OCORD, WAS USED TO PROCEED WITH THE SURGERY, BUT THE SAME ISSUE REOCCURRED. 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 (B)(6) 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 20505351 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071481, K150209. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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