Coated VICRYL VCP841DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031055797), received between Feb 25, 2025 and Jun 13, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

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 16, 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.

• MalfunctionJun 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR FUSION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LUMBAR FUSION, THE POP OFF SUTURE POPPED OFF. WHEN THEY WENT TO MAKE A PASS THE NEEDLE POPPED PREMATURELY. DEVICE IS AVAILABLE FOR RETURN. NO PATIENT HARM WAS REPORTED. CASE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203704 ↗
• MalfunctionApr 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF TOO EASILY. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753580 ↗
• MalfunctionFeb 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS POPPING OFF EASILY. ANOTHER LIKE DEVICE WAS USED TILL THE PROCEDURE WAS COMPLETED. ONE NEEDLE WAS MISSING BUT WAS RETRIEVED. NO X-RAY WAS NEEDED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460061 ↗
• MalfunctionFeb 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS POPPING OFF EASILY. ANOTHER LIKE DEVICE WAS USED TILL THE PROCEDURE WAS COMPLETED. ONE NEEDLE WAS MISSING BUT WAS RETRIEVED. NO X-RAY WAS NEEDED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460036 ↗

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