ORTHOCORD 223114Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886705008841), received between Jul 6, 2018 and Jun 19, 2026 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

6 other recalls cover devices cleared under the same FDA submission (K043298); 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 15 most recent of 15 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 24, 2024Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT AND TENDON RECONSTRUCTION SURGICAL PROCEDURE THE ORTHOCORD VIOLET/BLUE W/NDLES *PK/12 DEVICE THE SUTURE WAS BROKEN OFF WHEN TIGHTENED. 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. THIS IS REPORT 1 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21013396 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CAO Y, GAO S, CUI Z, FU Y, BAI L, SI G, FAN J, LV Y, ZHOU F. COMPARISON OF DIFFERENT IMMOBILISATION DURATIONS FOLLOWING OPEN SURGERY FOR ACUTE ACHILLES TENDON RUPTURE: A PROSPECTIVE COHORT STUDY. J ORTHOP SURG RES. 2024 AUG 21;19(1):497. DOI: 10.1186/S13018-024-04970-Y. PMID: 39169350; PMCID: PMC11337624. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS PROSPECTIVE COHORT STUDY WAS TO COMPARE DIFFERENT IMMOBILISATION DURATIONS IN ORDER TO DETERMINE THE OPTIMAL DURATION AFTER OPEN SURGERY FOR ACHILLES TENDON RUPTURE (ATR) REPAIR. BETWEEN MARCH 2019 TO MAY 2023, A TOTAL OF 1088 PATIENTS (1063 MALE AND 25 FEMALE; MEAN AGE, 35.0 YEARS, RANGE, 18¿60 YEARS) WHO UNDERWENT OPEN SURGERY FOR ACUTE ATR REPAIR WERE INCLUDED IN THE STUDY. THE PATIENTS WERE CATEGORISED INTO FOUR GROUPS (A, B, C, AND D) ACCORDING TO POSTOPERATIVE IMMOBILISATION DURATIONS OF 0, 2, 4, AND 6 WEEKS, RESPECTIVELY. ALL PATIENTS RECEIVED THE SAME SUTURE TECHNIQUE USING THE KRACKOW LOCKING LOOP TECHNIQUE WITH TWO W4843 (ETHIBOND OF JOHNSON & JOHNSON, US) NONABSORBABLE SUTURES AND THE MODIFIED KESSLER SUTURE TECHNIQUE WITH TWO REF223

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20505940 ↗
• MalfunctionJun 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM CHINA THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE, IT WAS DISCOVERED THAT THE SUTURE ON THE ORTHOCORD VIOLET/BLUE W/NDLES DEVICE DETACHED FROM THE ANCHOR. 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. 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 19566891 ↗
• MalfunctionDec 20, 2023Break; Break

  IT WAS REPORTED BY A SALES REP IN THAILAND THAT PREOPERATIVELY TO AN ACL(ANTERIOR CRUCIATE LIGAMENT) REPAIR SURGERY ON (B)(6) 2023, IT WAS OBSERVED THE ORTHOCORD VIOLET/BLUE W/NDLES *PK/12 DEVICE WAS BROKEN AND COULD NOT BE USED. 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 18362660 ↗
• MalfunctionApr 13, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT POSTOPERATIVELY TO AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE, A ORTHOCORD -ONE VIOLET/ONE BLUE BRAIDED COMPOSITE SUTURE 12/PK DEVICE WAS USED. ACCORDING TO THE REPORT, DUE TO KNEE PAIN AFTER SURGERY, THE PATIENT WENT TO THE HOSPITAL FOR REEXAMINATION AND FOUND THAT THE SUTURE WAS BROKEN. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 16732204 ↗
• MalfunctionFeb 14, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE OUTER PACKAGING ON THE ORTHOCORD -ONE VIOLET/ONE BLUE BRAIDED COMPOSITE SUTURE 12/PK DEVICE WAS DAMAGED. ACCORDING TO THE REPORT, THE PACKAGING WAS NOT OPENED. 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 16373154 ↗
• MalfunctionJul 25, 2018Break; Break

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT ONE OF HIS 4.75MM HEALIX ADVANCE KNOTLESS ANCHORS BROKE UPON INSERTION WHERE THE THREADS CHANGE AND TWO OF THIS ORTHOCORD SUTURES BROKE WHILE TESTING SUTURE STRENGTH DURING A ROTATOR CUFF PROCEDURE. THE SURGEON USED A SECOND HEALIX ADVANCE KNOTLESS ANCHOR AND NEW ORTHOCORD SUTURE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THE BROKEN ANCHOR WAS REMOVED ALONG WITH ALL BROKEN SUTURES. THERE WAS A FIVE MINUTE DELAY. ALL DEVICES WERE DISCARDED BY THE CUSTOMER ALREADY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7719358 ↗
• MalfunctionJul 25, 2018Break; Break

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT ONE OF HIS 4.75MM HEALIX ADVANCE KNOTLESS ANCHORS BROKE UPON INSERTION WHERE THE THREADS CHANGE AND TWO OF THIS ORTHOCORD SUTURES BROKE WHILE TESTING SUTURE STRENGTH DURING A ROTATOR CUFF PROCEDURE. THE SURGEON USED A SECOND HEALIX ADVANCE KNOTLESS ANCHOR AND NEW ORTHOCORD SUTURE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THE BROKEN ANCHOR WAS REMOVED ALONG WITH ALL BROKEN SUTURES. THERE WAS A FIVE MINUTE DELAY. ALL DEVICES WERE DISCARDED BY THE CUSTOMER ALREADY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7719119 ↗
• MalfunctionJul 6, 2018Break; Break

  AFFILIATE REPORTED THAT SUTURE BROKE, SURGERY WAS FINISHED SUCCESSFULLY WITH A SAME LIKE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7667187 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043298. One submission often covers many models, so check the product and lot details in each record.

• Z-1176-2013 · Mar 22, 2013 · Terminated
  ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. For use in general soft tissue approximation, and/or ligation,
• Z-1174-2013 · Mar 22, 2013 · Terminated
  ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, includin
• Z-1175-2013 · Mar 22, 2013 · Terminated
  ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including
• Z-1172-2013 · Mar 22, 2013 · Terminated
  ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
• Z-1173-2013 · Mar 22, 2013 · Terminated
  ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113. For use in general soft tissue approximation, and/or ligation, including orthoped
• Z-1315-2009 · Feb 2, 2009 · Terminated
  Orthocord Blue Braided Composite Suture, DePuy Mitek, A Johnson & Johnson Company, Meets USP and EP, except for diameter. DePuy Mitek, Inc. 325 Paramount Drive, Raynham, MA 02767