ORTHOCORD HEALIX TIRecalls & reported problems across all models

We found 6 models of ORTHOCORD HEALIX TI by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2018 and Apr 29, 2026 — classified as 8 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Break” (25 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ORTHOCORD HEALIX TI problems

ORTHOCORD HEALIX TI models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ORTHOCORD HEALIX TI 222242

  Screw, fixation, bone
  17 reports
• ORTHOCORD HEALIX TI 222245

  Screw, fixation, bone
  12 reports
• ORTHOCORD HEALIX TI 222253

  STAPLE, FIXATION, BONE
  11 reports
• ORTHOCORD HEALIX TI 222243

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  5 reports
• ORTHOCORD HEALIX TI 222241

  Screw, fixation, bone
  1 report
• ORTHOCORD HEALIX TI 222248

  STAPLE, FIXATION, BONE
  1 report

Recent ORTHOCORD HEALIX TI adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A ROTATOR CUFF REPAIR SURGERY WHERE (2X) 5.5 HEALIX TI ANCHOR W/OCORD DEVICES WERE USED, THE PATIENT EXPERIENCED A LOW-GRADE INFECTION IN THE SHOULDER. IT WAS FURTHER REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 25031006 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A ROTATOR CUFF REPAIR SURGERY WHERE (2X) 5.5 HEALIX TI ANCHOR W/OCORD DEVICES WERE USED, THE PATIENT EXPERIENCED A LOW GRADE INFECTION IN THE SHOULDER. IT WAS FURTHER REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 25026920 ↗
• MalfunctionMar 31, 2026Crack

  THIS IS REPORT 3 OF 3 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HEALIX ADVANCE ORTHOCORD DEVICE SUTURE BROKE AND FRAYED INTRAOPERATIVELY. THE SURGEON CONTINUED TO USE HEALIX ADVANCE BUT WOULD NOT USE THE ORTHOCORD DEVICE WITH THE WITH PERMACORD. 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 24742260 ↗
• MalfunctionFeb 7, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR PROCEDURE, IT WAS OBSERVED THAT THE DEVICE PULLED OUT. THERE WAS PATIENT INVOLVEMENT. 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 21333622 ↗
• MalfunctionSep 4, 2024Break; Break

  IT WAS REPORTED FROM COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURE ON THE 5.5 HEALIX TI ANCHR W/OC +NDLS DEVICE BURST EASILY UPON KNOTTING. THERE WAS PATIENT INVOLVEMENT. 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 20138088 ↗
• MalfunctionOct 31, 2023Break; Detachment of Device or Device Component; Difficult to Advance; Break; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT AT THE TIME OF THREADING THE 4.5 HEALIX TI ANCHOR W/OCORD DEVICE INTO THE BONE, IT REACHED HALFWAY, AND THE ANCHOR STOPPED ROTATING AND ONLY THE STEM BEGAN TO ROTATE. UPON INSPECTION, IT WAS REALIZED THAT THE TIP THAT HELD THE ANCHOR WAS RELEASED FROM THE STEM, CAUSING IT TO DETACH, AND THE TIP REMAINED INSIDE THE PATIENT WITH THE ANCHOR HALFWAY. THERE WAS A DELAY IN THE PROCEDURE; HOWEVER, THE DURATION OF THE DELAY WAS NOT SPECIFIED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18040916 ↗
• MalfunctionAug 30, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHILE THAT DURING AN SHOULDER REPAIR PROCEDURE ON (B)(6) 2023, A 5.5 HEALIX TI ANCHOR W/ ORTHOCORD DEVICE WAS USED. ACCORDING TO THE REPORT, THE ANCHOR PRESENTED FAILURE DURING USE AS IT WAS CUTTING THE SUTURES INTRAOPERATIVELY. 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 17651897 ↗
• MalfunctionJul 27, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES DEVICE CAME WITH A FRAYED SUTURE; AND THEREFORE, TRACTION COULD NOT BE MADE BECAUSE THE SUTURE BROKE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17408119 ↗
• MalfunctionApr 13, 2023Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT TWO 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES DEVICES WERE IN POOR CONDITION; AND THEREFORE, COULD NOT BE USED. ACCORDING TO THE REPORT, THE DEVICES WERE DEFORMED AND CROOKED THAT THEY COULD NOT PERFORM THE FIXATION. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 16735170 ↗
• MalfunctionApr 13, 2023Material Deformation; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT TWO 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES DEVICES WERE IN POOR CONDITION; AND THEREFORE, COULD NOT BE USED. ACCORDING TO THE REPORT, THE DEVICES WERE DEFORMED AND CROOKED THAT THEY COULD NOT PERFORM THE FIXATION. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 16735166 ↗
• MalfunctionApr 10, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN BELGIUM THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES DEVICE BROKE DURING THE KNOT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. WITH A DELAY OF 60 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709526 ↗
• MalfunctionNov 23, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES DEVICE BROKE FROM THE STEM UPON INSERTION. 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 15857729 ↗
• MalfunctionSep 6, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURES ON THE 5.5 HEALIX TI ANCHOR W/ ORTHOCORD DEVICE BROKE. 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 15364700 ↗
• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT BOTH THE ANCHOR AND SUTURE ON THE 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES DEVICE BROKE UPON IMPLANTATION. 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 15150168 ↗
• MalfunctionJun 1, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 5.5 HEALIX TI ANCHR W/OC +NDLS DEVICE WAS TORN WHEN TYING INTO A KNOT WITHOUT EXERTING ANY TYPE OF FORCE. 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 14568702 ↗

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