ORTHOCORDRecalls & reported problems across all models

We found 14 models of ORTHOCORD by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between Jul 6, 2018 and Jun 19, 2026 — classified as 8 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (40 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 problems

ORTHOCORD models

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

• ORTHOCORD 223104

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  18 reports
• ORTHOCORD 223114

  SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
  15 reports
• ORTHOCORD 223102

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  12 reports
• ORTHOCORD 223113

  SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
  5 reports
• ORTHOCORD 223115

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  3 reports
• ORTHOCORD 228145

  SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
  3 reports
• ORTHOCORD 223103

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  2 reports
• ORTHOCORD 223111

  SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
  2 reports
• ORTHOCORD 223116

  SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
  2 reports
• ORTHOCORD 223105

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report
• ORTHOCORD 228144

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report
• ORTHOCORD 223125

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report
• ORTHOCORD 223127

  SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
  1 report
• ORTHOCORD 223121

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report

Recent ORTHOCORD adverse event reports

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

• MalfunctionJun 19, 2026Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT BEFORE MENISCAL REPAIR SURGERY, ALTHOUGH THE OUTER PACKAGING WAS NOT DAMAGED, WHEN THE OUTER PACKING WAS OPENED IT WAS NOTED THAT THE INNER PACKAGING OF THE TWO ORTHOCORD DEVICES WERE UNSEALED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25560044 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE THAT THE ORTHOCORD VIOLET W/MO7 TAPRNDL SUTURE DEVICE WHEN TIGHTENED THE SUTURE, THE SUTURE WAS BROKEN OFF. 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 24835157 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ORTHOCORD VIOLET W/MO7 TAPRNDL SUTURE DEVICE WAS BROKEN. IT WAS REPORTED THAT 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 24680221 ↗
• MalfunctionJan 7, 2026Break

  IT WAS REPORTED THAT DURING SYNTHETIC SUTURE SURGERY, WHEN THE ORTHOCORDVIOLET/BLUE W/OS-6 NDLSPK/12 DEVICE WAS TIGHTENED, THE SUTURE 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 23996061 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-OP INFLAMMATION. THIS CASE IS FROM THE HEALTH AUTHORITY. THE PATIENT UNDERWENT COMPREHENSIVE RELEVANT EXAMINATIONS AND TESTS UPON ADMISSION, AND AFTER EXCLUDING SURGICAL CONTRAINDICATIONS, SURGERY WAS PERFORMED ON THE SAME DAY. AFTER SURGERY, KNEE JOINT STIFFNESS AND POOR SKIN WOUND HEALING WERE OBSERVED, AND HOSPITALIZATION WAS REQUIRED. SURGERY WAS PERFORMED TWO AND THREE MONTHS LATER, RESPECTIVELY. TWO MONTHS LATER, DURING THE SURGERY, INACTIVATED TISSUE WAS TAKEN AND SENT FOR GENERAL BACTERIAL CULTURE (RESULTS WERE NOT DETECTED). ONE WEEK AFTER THE SURGERY, THE VSD DEVICE WAS REMOVED AND THE SURGERY WAS PERFORMED AGAIN. DURING THE SURGERY, DAMAGED TISSUE WAS TAKEN AND SENT FOR GENERAL BACTERIAL CULTURE RESULTS. AFTER X DAYS, THE RESULTS SHOWED THAT STAPHYLOCOCCUS AUREUS SUBSP. HOMINIS (MULTIDRUG-RESISTANT). AFTER CONSULTATION WITH THE CLINICAL PHARMACY DEPARTMENT, VANCOMYCIN 1.0G, IVGTT, Q12H WERE GIVEN SLOWLY INTRAVENOUSLY. AFTER CURRENT MEDICATION, THE PATIENT'S INFECTION INDICATORS DECREASED, LIVER AND KIDNEY FUNCTION WERE GOOD, AND THE WOUND AND GENERAL CONDITION RECOVERED WELL.

  Patient problems: Unspecified Infection

  MAUDE report 23863012 ↗
• MalfunctionDec 12, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE NIT MENSCL SUT NDL W2-0 OC 5PK DEVICE WAS MISSING COMPONENTS. IT WAS REPORTED IN THE SERVICE ORDER THAT PRIOR TO A MENISCAL REPAIR SURGERY IT WAS OBSERVED THAT THE DEVICE WAS MISSING FEATURES. 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 23795481 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ORTHOCORD VIOLET W/MO7 TAPRNDL SUTURE WIRE BROKE WHEN UNWINDING THE SUTURE FROM PACKAGE. IT WAS REPORTED THAT ONLY ONE OF THE IMPLANTS WAS SUCCESSFUL DUE TO THE EVENT. IT WAS REPORTED THAT THERE WAS A 2-MINUTE DELAY IN THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22810680 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR A PATELLAR DISLOCATION, THE ORTHOCORD VIOLET/BLUE W/NDLES SUTURE DEVICE WAS USED TO FIX THE MEDIAL SUPPORTING LIGAMENT. THE LIGAMENT WAS NOTED TO BE STABLE. THE PROCEDURE WAS REPORTED TO HAVE GONE SMOOTHLY. THE PATIENT WAS DISCHARGED. EIGHTY EIGHT DAYS AFTER THE PROCEDURE, THE PATIENT COMPLAINED THAT THE WOUND CONTINUED TO HEAL POORLY. THE PATIENT UNDERWENT A DEBRIDEMENT AND SUTURE AND VSD COVERING SURGERY ON (B)(6) 2025. THE WOUND HEALED WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Impaired Healing

  MAUDE report 22803705 ↗
• MalfunctionJul 11, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE ORTHOCORD VIOLET W/MO7 TAPRNDL DEVICE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480478 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SURGERY DUE TO LEFT KNEE PATELLAR DISLOCATION. THE ORTHOCORD VIOLET/BLUE W/NDLES DEVICE WAS USED DURING THE PROCEDURE AND IT WAS REPORTED THAT THE SURGERY WENT SMOOTHLY. IT WAS REPORTED THAT THE PATIENT HAD POOR WOUND HEALING AFTER THE PROCEDURE AND REVISITED THE DOCTOR. THE PATIENT HAD POST-OP INFECTION, POST-OP INFLAMMATION AND WOUND SECRETION. THE PATIENT WAS ADMITTED DUE TO "1 MONTH AFTER LEFT KNEE PATELLAR DISLOCATION SURGERY, WOUND REDNESS AND SWELLING WITH EXUDATION FOR 3 WEEKS" 30 DAYS AFTER SURGERY. DIAGNOSIS ON ADMISSION: "1. POSTOPERATIVE INFECTION OF PATELLAR DISLOCATION OF LEFT KNEE; 2. POSTOPERATIVE INCISION INFECTION OF LEFT ANKLE TENECTOMY". THE PATIENT PERFECTED RELEVANT EXAMINATIONS ON ADMISSION AND RECEIVED SURGERY 2 DAYS AFTER ADMISSION. DURING THE SURGERY, THE POORLY HEALED SKIN AT THE LOCAL SITE WAS REMOVED, AND STICKY PINK PURULENT EFFUSION WAS FOUND UNDER THE SKIN. POTENTIAL LACUNA FORMATION WAS OBSERVED AT THE LOCAL SITE, PART OF THE SURROUNDING TISSUES WERE NECROTIC AND LIQUIFIED TISSUES, AND THE NECROTIC TISSUE, SUTURE KNOTS, AND FLUID ACCUMULATION WITH POOR GROWTH IN THE WOUND WERE THOROUG

  Patient problems: Bacterial Infection; Calcium Deposits/Calcification; Fever; Fluid Discharge; Impaired Healing; Inflammation; Necrosis

  MAUDE report 22461155 ↗
• InjuryJul 9, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR SURGERY OF THE SHOULDER AND CLAVICULAR JOINT DISLOCATION AT THE END OF (B)(6) 2025. DURING THE SURGERY, THE SURGEON USED THREE RGDLOOP ADJUSTABLE STND DEVICES FOR SOFT TISSUE FIXATION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SURGEON CUT OFF THE WHITE SUTURE OF THE DEVICE AND USED TWO ORTHOCORD VIOLET W/MO-6 NDLS DEVICES INSTEAD TO PASS THE TITANIUM PLATE FOR FIXATION. IT WAS REPORTED THAT POSTOPERATIVE X-RAY WAS UNREMARKABLE. SUBSEQUENTLY, THE PATIENT FELT SHOULDER DISCOMFORT AND WENT TO THE HOSPITAL FOR TREATMENT (THE SPECIFIC PROCESS, OCCURRENCE DATE, EXAMINATION RESULTS AND DIAGNOSIS WERE UNKNOWN). ON (B)(6) 2025, A SECOND SURGERY WAS PERFORMED FOR REFIXATION. DURING THE SURGERY, IT WAS FOUND THAT THE SUTURES OF THE ORTHOCORD VIOLET W/MO-6 NDLS DEVICES WERE BROKEN. IT WAS REPORTED THAT CURRENTLY, THE PATIENT'S CONDITION IS STABLE AND NO FURTHER ADVERSE EVENT REPORTS HAVE BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Discomfort

  MAUDE report 22460911 ↗
• InjuryJul 9, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR SURGERY OF THE SHOULDER AND CLAVICULAR JOINT DISLOCATION AT THE END OF (B)(6) 2025. DURING THE SURGERY, THE SURGEON USED THREE RGDLOOP ADJUSTABLE STND DEVICES FOR SOFT TISSUE FIXATION. DURING THE PROCEDURE IT WAS REPORTED THAT THE SURGEON CUT OFF THE WHITE SUTURE OF THE DEVICE AND USED TWO ORTHOCORDVIOLET W/MO-6 NDLS DEVICES INSTEAD TO PASS THE TITANIUM PLATE FOR FIXATION. IT WAS REPORTED THAT POSTOPERATIVE X-RAY WAS UNREMARKABLE. SUBSEQUENTLY, THE PATIENT FELT SHOULDER DISCOMFORT AND WENT TO THE HOSPITAL FOR TREATMENT (THE SPECIFIC PROCESS, OCCURRENCE DATE, EXAMINATION RESULTS AND DIAGNOSIS WERE UNKNOWN). ON (B)(6) 2025, A SECOND SURGERY WAS PERFORMED FOR REFIXATION. DURING THE SURGERY, IT WAS FOUND THAT THE SUTURES OF THE ORTHOCORDVIOLET W/MO-6 NDLS DEVICES WERE BROKEN. IT WAS REPORTED THAT CURRENTLY, THE PATIENT'S CONDITION IS STABLE AND NO FURTHER ADVERSE EVENT REPORTS HAVE BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Discomfort

  MAUDE report 22460870 ↗
• MalfunctionMar 14, 2025Break; Break

  IT WAS REPORTED THAT THE THREE (X3) ORTHOCORD VIOLET/BLUE W/NDLES DEVICES HAD THREE SEPARATE BLUE BRAIDED SUTURES, FROM THIS LOT BROKE UNDER MINIMAL TENSION. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21605961 ↗
• MalfunctionMar 14, 2025Break; Break

  IT WAS REPORTED THAT THE THREE (X3) ORTHOCORD VIOLET/BLUE W/NDLES DEVICES HAD THREE SEPARATE BLUE BRAIDED SUTURES, FROM THIS LOT BROKE UNDER MINIMAL TENSION. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21605958 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ORTHOCORD BLUE W/O NDLES DEVICE SUTURE WAS BROKEN OFF WHEN THE SUTURE WAS TIGHTENED. 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 21444813 ↗

Other Medos International Sàrl products

• TRUESPAN ORTHOCORD6 models · 4,109 reports
• FMS39 models · 3,588 reports
• EXPEDIUM291 models · 3,312 reports
• EXPEDIUM VERSE90 models · 2,686 reports
• EXPRESSEW6 models · 2,459 reports
• OMNISPAN ORTHOCORD3 models · 1,581 reports
• HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
• PROWLER SELECT9 models · 1,066 reports