Coated VICRYL VCP259HRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705031051782), received between Jul 3, 2018 and Jan 3, 2025 — classified as 25 injuries, 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THA ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT DEVELOPED ERYTHEMA AND DRAINAGE. REQUIRED REOPERATION, I &D, ON (B)(6) 2024 AND (B)(6) 2024. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Granuloma

  MAUDE report 21068822 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA ON (B)(6)2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT DEVELOPED ERYTHEMA AND DRAINAGE FROM INCISION AND REQUIRED ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Granuloma

  MAUDE report 21068820 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT DEVELOPED ERYTHEMA OF INCISION. NO DRAINAGE. REQUIRED ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Granuloma

  MAUDE report 21068819 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACL REPAIR ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT DEVELOPED SCABBING, DRAINAGE OVER SUPERIOR INCISION, THE SUTURE WAS USED IN THIS SITE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Granuloma

  MAUDE report 21068818 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT DEVELOPED INCISIONAL DRAINAGE AND REQUIRED KNEE ASPIRATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Granuloma

  MAUDE report 21068817 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THA ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT UNDERWENT AN I & D REOPERATION ON (B)(6) 2024. THE PATIENT ALSO UNDERWENT AN I &D AND WOUND CLOSURE REOPERATION ON (B)(6) 2024. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma

  MAUDE report 21068816 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THA ON (B)(6)2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT UNDERWENT A HIP REVISION ON (B)(6)2024 FOR PERIPROSTHETIC JOINT INFECTION (PJI). ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Unspecified Infection

  MAUDE report 21068815 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT DEVELOPED STITCH GRANULOMA AND REQUIRED PICOS VAC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma

  MAUDE report 21068814 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT DEVELOPED INCISIONAL DRAINAGE AND REQUIRED PICOS VAC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Granuloma

  MAUDE report 21068813 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANKLE ORIF ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT WAS SENT TO WOUND CARE FOR DRAINAGE AND WOUND HEALING ISSUES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Impaired Healing

  MAUDE report 21067350 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT DEVELOPED SCABBING AND DRAINAGE. THE SCABS WERE REMOVED. THE PATIENT DID NOT REQUIRE ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Granuloma

  MAUDE report 21067347 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TKA ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT EXPERIENCED A WOUND DEHISCENCE AND REQUIRED REOPERATION FOR WOUND CLOSURE ON (B)(6) 2024. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Wound Dehiscence

  MAUDE report 21067345 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACL REPAIR ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT DEVELOPED ERYTHEMA AND DRAINAGE FROM THE SUPERIOR INCISION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Granuloma

  MAUDE report 21067339 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED A STITCH GRANULOMA WHICH WAS REMOVED IN THE CLINIC. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma

  MAUDE report 21067333 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANKLE ORIF ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT DEVELOPED ERYTHEMA AND DRAINAGE. A PICOS VAC WAS PLACED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Granuloma

  MAUDE report 21067332 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANKLE ORIF ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT DEVELOPED ERYTHEMA AND DRAINAGE AND REQUIRED HARDWARE REMOVAL ON (B)(6) 2024. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Granuloma

  MAUDE report 21067329 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TSA ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A GRANULOMA. THE PATIENT DEVELOPED DRAINAGE AND REQUIRED A WASHOUT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Granuloma

  MAUDE report 21067327 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A LUMBAR LAMINECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE BROKE DURING USE IN A SPINE CASE. THE NEEDLE WAS RETRIEVED FROM PATIENT. THE SURGERY WAS DELAYED BY THIRTY MINUTES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646173 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. POST-OPERATIVELY, THE PATIENT DEVELOPED ABSCESS AT THE SUTURE SITE AND WOUND DEHISCENCE NOTED AS MILD OPEN AREAS, THERE WERE NO COMPLETE OPENINGS. THE SUTURE WAS REMOVED, AND ANTIBIOTICS WERE PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Wound Dehiscence

  MAUDE report 10723389 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. POST-OPERATIVELY, THE PATIENT DEVELOPED ABSCESS AT THE SUTURE SITE AND WOUND DEHISCENCE NOTED AS MILD OPEN AREAS, THERE WERE NO COMPLETE OPENINGS. THE SUTURE WAS REMOVED, AND ANTIBIOTICS WERE PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Wound Dehiscence

  MAUDE report 10723378 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FASCIOTOMY SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. POST-OPERATIVELY, THE PATIENT DEVELOPED ABSCESS AT THE SUTURE SITE AND WOUND DEHISCENCE NOTED AS MILD OPEN AREAS, THERE WERE NO COMPLETE OPENINGS. THE SUTURE WAS REMOVED, AND ANTIBIOTICS WERE PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Wound Dehiscence

  MAUDE report 10723365 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. POST-OPERATIVELY, THE PATIENT DEVELOPED ABSCESS AT THE SUTURE SITE AND WOUND DEHISCENCE NOTED AS MILD OPEN AREAS, THERE WERE NO COMPLETE OPENINGS. THE SUTURE WAS REMOVED, AND ANTIBIOTICS WERE PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Wound Dehiscence

  MAUDE report 10723182 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HAND SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. POST-OPERATIVELY, THE PATIENT DEVELOPED ABSCESS AT THE SUTURE SITE AND WOUND DEHISCENCE NOTED AS MILD OPEN AREAS, THERE WERE NO COMPLETE OPENINGS. THE SUTURE WAS REMOVED, AND ANTIBIOTICS WERE PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Wound Dehiscence

  MAUDE report 10723176 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2020 AND THE SUTURE WAS USED. POST-OPERATIVELY, THE PATIENT DEVELOPED ABSCESS AT THE SUTURE SITE AND WOUND DEHISCENCE NOTED AS MILD OPEN AREAS, THERE WERE NO COMPLETE OPENINGS. THE SUTURE WAS REMOVED, AND ANTIBIOTICS WERE PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Wound Dehiscence

  MAUDE report 10723161 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2020 AND THE SUTURE WAS USED. POST-OPERATIVELY, THE PATIENT DEVELOPED ABSCESS AT THE SUTURE SITE AND WOUND DEHISCENCE NOTED AS MILD OPEN AREAS, THERE WERE NO COMPLETE OPENINGS. THE SUTURE WAS REMOVED, AND ANTIBIOTICS WERE PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Wound Dehiscence

  MAUDE report 10723136 ↗

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