ORTHOCORD 223103Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705008742), received between Jun 30, 2020 and Jun 30, 2020 — classified as 2 malfunctions.

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

• MalfunctionJun 30, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE, WHILE USING AN ORTHOCORD VIOLET SUTURE WITH OS-6 NEEDLES, SINGLE PK, THE NEEDLE TORE OFF FROM SUTURE. THEN THEY OPENED A NEW PACKAGE FROM ANOTHER LOT AND IT ALSO TORE OFF. A NEW SUTURE BLISTER WAS OPENED TO COMPLETE PROCEDURE WITH A SURGICAL DELAY OF THREE MINUTES. NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 10212920 ↗
• MalfunctionJun 30, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE, WHILE USING AN ORTHOCORD VIOLET SUTURE WITH OS-6 NEEDLES, SINGLE PK, THE NEEDLE TEARED OFF FROM SUTURE. THEN THEY OPENED A NEW PACKAGE FROM ANOTHER LOT AND IT ALSO TEARED OFF. A NEW SUTURE BLISTER WAS OPENED TO COMPLETE PROCEDURE WITH A SURGICAL DELAY OF THREE MINUTES. NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 10212919 ↗

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