Coated VICRYL VCP839DRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031055766), received between Oct 7, 2021 and May 1, 2025 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR HIP PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ABOUT 4 WEEKS AFTER THE SURGERY, BETWEEN DECEMBER AND MARCH, THE PATIENT DEVELOPED A SUTURE ABSCESS AND/OR THE WOUND OPENED UP. THE WOUND WOULD DEHISCE AND WE WOULD HAVE TO OPEN UP THE AREA WASH IT OUT IN THE OR AND RE-CLOSE. THE HCP DOES NOT KNOW IF THIS IS AN ISSUE WITH THE LOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Wound Dehiscence

  MAUDE report 21944329 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR HIP PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ABOUT 4 WEEKS AFTER THE SURGERY, BETWEEN (B)(6), THE HAD A WOUND DEHISCENCE AND THE PATIENT'S HIP GOT A DEEP INFECTION AND WE HAD TO EXPLANT ALL HER HARDWARE. SHE IS CURRENTLY ON ANTIBIOTICS AND WILL GET REPLANTED LATER. THE HCP DOES NOT KNOW IF THIS IS AN ISSUE WITH THE LOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 21944323 ↗
• MalfunctionApr 1, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SUTURE WAS OPENED AND THERE WAS A HAIR IN THE PACKAGE. CASE WAS COMPLETED WITH A LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738274 ↗
• InjuryAug 2, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR 4-LUMBAR 5 POSTERIOR SPINAL INSTRUMENTED FUSION AND DECOMPRESSION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST OP THE SUTURES WERE NOT DISSOLVING AND WERE BEING REJECTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Inflammation; Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 17440525 ↗
• InjuryAug 1, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR 4-LUMBAR 5 POSTERIOR SPINAL INSTRUMENTED FUSION AND DECOMPRESSION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST OP THE SUTURES WERE NOT DISSOLVING AND WERE BEING REJECTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Bacterial Infection; Discomfort; Fluid Discharge; Impaired Healing; Pocket Erosion; Wound Dehiscence

  MAUDE report 17439523 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABSCESS SUTURE ABSCESSES WEEK 7 TO 10 POST OP APPROXIMATELY. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTIC, MUPROCIN, AND CLEANING WITH PEROXIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess

  MAUDE report 12637451 ↗
• InjuryOct 7, 2021Adverse 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/ TKA PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED ON SUBCUTANEOUS LAYER . IT WAS REPORTED THAT FIVE TO SIX WEEKS POST OP THE PATIENT RETURNED WITH SPITTING SUTURE. THE SUTURE WAS ABLE TO BE REMOVED DURING POST-OP VISIT AND NO REOPERATION OR RE-SUTURING NEEDED. THE PATIENT EXPERIENCED ABSCESS SUTURE ABSCESS APPROXIMATELY WEEK 7 TO 10 POST OP. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTIC, MUPROCIN, AND CLEANING WITH PEROXIDE. THE INCISION WAS HEALED APPROPRIATELY. THE PATIENT IS DOING FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Pocket Erosion

  MAUDE report 12595582 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABSCESS SUTURE ABSCESSES WEEK 7 TO 10 POST OP APPROXIMATELY. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTIC, MUPROCIN, AND CLEANING WITH PEROXIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess

  MAUDE report 12595572 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABSCESS SUTURE ABSCESSES WEEK 7 TO 10 POST OP APPROXIMATELY. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTIC, MUPROCIN, AND CLEANING WITH PEROXIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess

  MAUDE report 12595558 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABSCESS SUTURE ABSCESSES WEEK 7 TO 10 POST OP APPROXIMATELY. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTIC, MUPROCIN, AND CLEANING WITH PEROXIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess

  MAUDE report 12595552 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABSCESS SUTURE ABSCESSES WEEK 7 TO 10 POST OP APPROXIMATELY. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTIC, MUPROCIN, AND CLEANING WITH PEROXIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess

  MAUDE report 12595545 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABSCESS SUTURE ABSCESSES WEEK 7 TO 10 POST OP APPROXIMATELY. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTIC, MUPROCIN, AND CLEANING WITH PEROXIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess

  MAUDE report 12595536 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABSCESS SUTURE ABSCESSES WEEK 7 TO 10 POST OP APPROXIMATELY. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTIC, MUPROCIN, AND CLEANING WITH PEROXIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess

  MAUDE report 12595531 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABSCESS SUTURE ABSCESSES WEEK 7 TO 10 POST OP APPROXIMATELY. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTIC, MUPROCIN, AND CLEANING WITH PEROXIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess

  MAUDE report 12595526 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABSCESS SUTURE ABSCESSES WEEK 7 TO 10 POST OP APPROXIMATELY. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTIC, MUPROCIN, AND CLEANING WITH PEROXIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess

  MAUDE report 12595392 ↗

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