ORTHOCORD 223105Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705008766), received between Jun 10, 2021 and Jun 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE THREAD ON THE ORTHOCORD VIOLET SUTURE WITHOUT NEEDLES, SINGLE PK SNAPPED AS THEY TRIED TO KNOT IT ON THE ANCHOR. 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 11976863 ↗

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