Coated VICRYL VCPB260HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031056343), received between Sep 19, 2019 and Aug 10, 2026 — classified as 4 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Material Integrity Problem

  HOLDL13. It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The needle had been detached from the suture. It was not a control release needle. This event was found before use. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50200498 ↗
• MalfunctionDec 23, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT, DURING A UNICOMPARTMENTAL KNEE ARTHROPLASTY, WHEN THE PACKAGE OF VCPB260H WAS OPENED, THERE WAS VCPB978H IN THE STERILE PACKAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13082024 ↗
• MalfunctionDec 10, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE BODY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975328 ↗
• MalfunctionSep 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2019 AND THE SUTURE WAS USED. IT WAS ALSO REPORTED THAT THE NEEDLE IS DETACHING FROM THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9086293 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2024 · May 10, 2024 · Open, Classified
  VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
• Z-1310-2009 · Feb 2, 2009 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and