ORTHOCORD 223125Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705022939), received between Jan 28, 2019 and Jan 28, 2019 — classified as 1 malfunction.

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

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 16, 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.

• MalfunctionJan 28, 2019Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE #4-0 OC VIOLET20LOOP PK/12 SUTURE DEVICE BROKE AT THE JUNCTION BETWEEN THE NEEDLE AND THE SUTURE. ACCORDING TO THE REPORTER, THE NEEDLE SNAPPED OFF THE SUTURE. IT WAS REPORTED THAT THE SURGEON BELIEVED THAT THE EYELET ON THE NEEDLE WAS A WEAK POINT AND WOULD BREAK WHEN PULLED FIRMLY. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGERY. THE SURGEON USED A MAYO NEEDLE AND TICRON SUTURE 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 8282510 ↗