ORTHOCORD 223102Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705008735), received between Aug 21, 2018 and Jul 9, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K040004); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 8 FOR (B)(4). IT WAS REPORTED THROUGH CLINICAL RESEARCH STUDY THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION WITH LATERAL COLLATERAL LIGAMENT (LCL) REPAIR PROCEDURES ON (B)(6) 2023, AN ORTHOCORDVIOLET W/MO-6 NDLS DEVICE WAS USED. ACCORDING TO THE REPORT, POSTOPERATIVELY ON (B)(6) 2024, THE PATIENT HAD JOINT STIFFNESS WITH REDUCED RANGE OF MOTION. IT WAS REPORTED THAT THE EVENT DID NOT RESULT IN A REOPERATION/REVISION PROCEDURE. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19950428 ↗
• MalfunctionSep 21, 2018Break; Break

  IT WAS REPORTED THAT THREAD BROKE BY FRAYING DURING TRACTION. INCIDENT DIFFICULT TO CATCH. PROCEDURE HAS BEEN EXTENDED. NO MORE INFORMATION TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7899291 ↗
• MalfunctionSep 21, 2018Break; Break

  IT WAS REPORTED THAT THREAD BROKE BY FRAYING DURING TRACTION. INCIDENT DIFFICULT TO CATCH. PROCEDURE HAS BEEN EXTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7899249 ↗
• MalfunctionSep 14, 2018Material Frayed; Material Frayed

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE ORTHOCORD VIOLET W/MO-6 NDLS PK/12 THREAD DEVICE WAS RIPPED OVER AND OVER AGAIN DURING ACL SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 7876092 ↗
• MalfunctionSep 13, 2018Material Frayed; Material Frayed

  THIS IS REPORT 3 FOR 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE ORTHOCORD VIOLET W/MO-6 NDLS PK/12 THREAD DEVICE WAS RIPPED OVER AND OVER AGAIN DURING ACL SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 7874215 ↗
• MalfunctionSep 13, 2018Material Frayed; Material Frayed

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT THE ORTHOCORDVIOLET W/MO-6 NDLS PK/12 THREAD DEVICE WAS RIPPED OVER AND OVER AGAIN DURING ACL SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 7874210 ↗
• MalfunctionAug 21, 2018Material Frayed; Material Frayed

  THIS IS REPORT 3 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT FOUR SUTURE DEVICES BROKE EASILY. ACCORDING TO THE REPORT, THE TENSILE STRENGTH OF THE SUTURES WERE WEAK. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 7801495 ↗
• MalfunctionAug 21, 2018Material Frayed; Material Frayed

  THIS IS REPORT 4 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT FOUR SUTURE DEVICES BROKE EASILY. ACCORDING TO THE REPORT, THE TENSILE STRENGTH OF THE SUTURES WERE WEAK. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 7801485 ↗
• MalfunctionAug 21, 2018Material Frayed; Material Frayed

  THIS IS REPORT 2 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT FOUR SUTURE DEVICES BROKE EASILY. ACCORDING TO THE REPORT, THE TENSILE STRENGTH OF THE SUTURES WERE WEAK. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 7801480 ↗
• MalfunctionAug 21, 2018Material Frayed; Material Frayed

  THIS IS REPORT 1 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT FOUR SUTURE DEVICES BROKE EASILY. ACCORDING TO THE REPORT, THE TENSILE STRENGTH OF THE SUTURES WERE WEAK. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 7801476 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040004. One submission often covers many models, so check the product and lot details in each record.

• Z-1316-2009 · Feb 2, 2009 · Terminated
  Orthocord Suture, DePuy Mitek, a Johnson & Johnson Company; . DePuy Mitek, Inc. 325 Paramount Drive, Raynham, MA 02767 Sutures are intended for general soft tissue approximation a