Coated VICRYL VCP616HRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031054479), received between Jan 23, 2018 and Jan 23, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED IN JOURNAL ARTICLE ¿BARBED VERSUS TRADITIONAL SUTURES: CLOSURE TIME, COST, AND WOUND RELATED OUTCOMES IN TOTAL JOINT ARTHROPLASTY¿ THAT PURPOSE OF THE STUDY WAS TO PROSPECTIVELY INVESTIGATE BARBED SUTURES BY COMPARING THEM TO TRADITIONAL SUTURES. THE PATIENT UNDERWENT TOTAL JOINT ARTHROPLASTY TKA ON UNKNOWN DATE BETWEEN 08/2010 AND 10/2010 AND SUTURE WAS USED WITH RUNNING TECHNIQUE ON THE FAT TISSUE. POST OPERATIVELY THE PATIENT MAY HAVE EXPERIENCED PROMINENT SUTURE TREATED WITH REMOVAL WITH FORCEPS AND APPLICATION OF ANTIBIOTIC OINTMENT. THE PATIENT POSSIBLY EXPERIENCED SUPERFICIAL INFECTION SUCCESSFULLY TREATED WITH ORAL ANTIBIOTICS. IN CONCLUSION, BARBED SUTURES ARE ASSOCIATED WITH A DECREASED TIME TO WOUND CLOSURE FOLLOWING TKA'S AND THA'S AND THE FINANCIAL BENEFIT ASSOCIATED WITH SAVING TIME IN THE OPERATING ROOM IS SIGNIFICANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body Reaction; Unspecified Infection

  MAUDE report 7213408 ↗

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