ORTHOCORD 223104Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886705008759), received between Jan 28, 2019 and Apr 9, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 8, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, THE ORTHOCORD VIOLET W/MO7 TAPRNDL DEVICE, WHEN TIGHTENING THE SUTURE, 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 20642380 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE ORTHOCORD VIOLET W/MO7 TAPRNDL DEVICE WHEN TIGHTENED THE SUTURE, 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 20084795 ↗
• MalfunctionNov 7, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED FROM CHINA BY A SALES REP ON (B)(6) 2023, THAT PRIOR TO A SURGICAL PROCEDURE, IT WAS OBSERVED THAT 2X ORTHOCORD VIOLET W DEVICE PACKAGES WERE UNSEALED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS EVENT 2 OF 2 OF THE SAME EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083929 ↗
• MalfunctionNov 7, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED FROM CHINA BY A SALES REP ON (B)(6) 2023, THAT PRIOR TO A SURGICAL PROCEDURE, IT WAS OBSERVED THAT 2X ORTHOCORD VIOLET W DEVICE PACKAGES WERE UNSEALED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS EVENT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083928 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE ON (B)(6) 2023 THE ORTHOCORD VIOLET W/MO7 TAPRNDL DEVICE SUTURE BROKE OFF WHEN TIGHTENED. CHANGED TO ANOTHER ORTHOCORD VIOLET W/MO7 TAPRNDL DEVICE IN ORDER TO CONTINUE THE SURGERY AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010734 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE ON (B)(6) 2023 THE ORTHOCORD VIOLET W/MO7 TAPRNDL DEVICE SUTURE BROKE OFF WHEN TIGHTENED. CHANGED TO ANOTHER ORTHOCORD VIOLET W/MO7 TAPRNDL DEVICE IN ORDER TO CONTINUE THE SURGERY AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010731 ↗
• MalfunctionMar 29, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A JOINT REPLACEMENT PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT A HAIR WAS INSIDE THE PACKAGING OF THE ORTHOCORD - VIOLET W NEEDLES 12/PK DEVICE WHEN IT WAS FIRST OPENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639752 ↗
• MalfunctionOct 29, 2021Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ORTHOCORD VIOLET W/MO7 TAPRNDL SUTURE DEVICE BROKE AT THE TIME OF KNOTTING. 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 12721337 ↗
• MalfunctionOct 29, 2021Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ORTHOCORD VIOLET W/MO7 TAPRNDL SUTURE DEVICE BROKE AT THE TIME OF KNOTTING. 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 12721325 ↗
• MalfunctionJun 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE NEEDLE DISASSEMBLED WHEN THE FIRST STITCH PASSED THROUGH THE TISSUE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10207292 ↗
• MalfunctionMar 25, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT THE RGDLOOP ADJUSTABLE LONG THE WHITE THREAD IN CHARGE OF RAISING THE GRAFT BROKE AFTER TENSIONING THE GRAFT, IN ADDITION THE ORTHOCORD VIOLET W/MO7 TAPRNDL PK/12 THE PLATE THAT HOLDS THE GRAFT IS BROUGHT AND CORTICAL FIXATION IS LOST. NO PATIENT CONSEQUENCES, THERE IS A SURGICAL DELAY OF 45 MINUTES REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9879469 ↗
• MalfunctionMar 24, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA EMAIL THAT DURING PROCEDURE THE ORTHOCORD VIOLET W/MO7 TAPRNDL * PK/12 SUTURE THREAD WAS DISASSEMBLED FROM THE NEEDLE. THE PROCEDURE WAS COMPLETED BY PASSING ANOTHER SUTURE WHICH IT HAS WORKED CORRECTLY. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9873866 ↗
• MalfunctionNov 25, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE ORTHOCORD VIOLET W/MO7 TAPRNDL * PK/12 SPLIT IN HALF FOR NO REASON. IT WAS REPORTED THAT THE EVENT OCCURRED AFTER PASSING THE SUTURE THROUGH THE TISSUES OF THE ROTATOR CUFF WHEN THE SURGEON PULLED BOTH ENDS OF THE DEVICE. IT WAS REPORTED THAT THE SURGEON DID NOT ALLOW TO CHARFE THE SUTURE AND ASKED TO CHECK THE QUALITY. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369148 ↗
• MalfunctionJan 28, 2019Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ORTHOCORD VIOLET W/MO7 TAPRNDL, PK/12 SUTURE DEVICE BROKE AT THE FINAL BASE OF THE GRAFT WHEN IT WAS PULLED. ACCORDING TO THE REPORTER, THE EVENT OCCURRED WHEN THE MIRACLE INTERFERENCE SCREW WAS TO BE PLACED TO PREPARE THE GRAFT. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 8281005 ↗

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