Coated VICRYL VCP267HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031051874), received between Oct 29, 2020 and Aug 22, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2022Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY AN EMPLOYEE PER THE ACCOUNT: "THE OR AT LD HAS BEEN NOTICING SMALL HOLES IN THE SUTURE PACKAGING AFTER THEY OPEN THEM. THE INDIVIDUAL SUTURES COME IN ¿FOIL¿ PACKS AND IF THE PACKS GET A BEND OR CREASE IN THEM, THERE IS A CHANCE IT MAY CREATE A WHOLE. ETHICON DOES PACKAGE SOME OF THEIR SUTURE LIKE PROLENE IN A CLEAR PLASTIC PEEL PACKS THAT HOLD UP BETTER." IT IS UNKNOWN IF THE DEVICES ARE AVAILABLE FOR RETURN.. ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272458 ↗
• MalfunctionOct 29, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL HIP REPLACEMENT PROCEDURE ON AN UNKNOWN DATE; AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE UPON CLOSING THE DEEP FASCIA. IT WAS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10755758 ↗

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