ORTHOCORD 223111Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705008810), received between Jan 27, 2021 and Feb 24, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJan 27, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ORTHOCORD BLUE W/O NDLES *PK/12 DEVICE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS ITS FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11238187 ↗

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-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-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-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-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