ORTHOCORD 223113Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705008834), received between Nov 14, 2023 and Dec 31, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2024Break; Break

  REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE ORTHOCORD VIOLET/BLUE W/O NDLES DEVICE SUTURE WAS BROKEN OFF WHEN TIGHTENED. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 21046899 ↗
• MalfunctionDec 31, 2024Break; Break

  REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE ORTHOCORD VIOLET/BLUE W/O NDLES DEVICE SUTURE WAS BROKEN OFF WHEN TIGHTENED. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 21046894 ↗
• MalfunctionDec 31, 2024Break; Break

  REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE ORTHOCORD VIOLET/BLUE W/O NDLES DEVICE SUTURE WAS BROKEN OFF WHEN TIGHTENED. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 21046888 ↗
• MalfunctionDec 24, 2024Break; Break

  IT WAS REPORTED THAT PRIOR TO A SHOULDER SCOPE SURGICAL PROCEDURE THE ORTHOCORD VIOLET/BLUE W/O NDLES DEVICE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21011371 ↗
• MalfunctionNov 14, 2023Crack; Crack

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A PATELLAR DISLOCATION RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ORTHOCORD VIOLET/BLUE W/O NDLES *PK/12 DEVICE WAS FRAYED WHEN TIGHTENED. 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 18133184 ↗

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-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-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-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-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-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