Kerlix 6716Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521058460), received between Aug 23, 2021 and Aug 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 23, 2021Break; Break

  THE CUSTOMER REPORTED THAT THE ORTHO SURGEON IS CONCERNED ABOUT THE INTEGRITY OF THE CURRENT KERLIX ROLLS THAT ARE ON SUPPLY STATING THAT THE BANDAGES SHOULD BE STRONG ENOUGH TO TUG ON AND NOT BREAK BUT RECENTLY THE ROLLS WILL EASILY BREAK ONCE THEY ARE TUGGED ON. IT IS ALMOST LIKE THEY ARE DRY ROTTED. THEY OPENED A NEW ONE WITH AN EXPIRATION DATE OF 20-APR-2026 AND IT SHREDDED AS SOON AS IT WAS TUGGED ON. PER THE CUSTOMER ON 13-AUG-2021 IT IS UNKNOWN HOW MANY ROLLS WERE AFFECTED, THE ISSUES OCCURRED DURING PATIENT USE ON AN UNKNOWN NUMBER OF PATIENTS DURING SURGERY. NO KNOWN INJURIES AT THIS TIME PER THE REPORTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356764 ↗