Coated VICRYL VCP467H (UDI 10705031053496)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031053496), received between Mar 13, 2020 and Feb 9, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT ON UNKNOWN DATE AND THEY RECEIVED THE WRONG SUTURE PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. IN GATHERING INFORMATION TO RETURN THE INCORRECT PRODUCT IT WAS FOUND THAT THE LOT NUMBER ON THE BOX DID NOT EXACTLY MATCH THE PRODUCT CODE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502504 ↗
• MalfunctionJun 8, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN SUTURE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE WHEN PLACING THE LAST SKIN STITCH AND THE NEEDLE WAS RETRIEVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957475 ↗
• MalfunctionMar 13, 2020Break; Break

  IT WAS REPORTED BY VET THAT THE ANIMAL UNDERWENT AN ANIMAL STERILIZATION SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED TO LIGATE THE OVARY. IT WAS REPORTED THAT DURING PROCEDURE, THE SUTURE BROKE A BIT FROM THE NEEDLE END, BUT NOT IN THE KNOT. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9830446 ↗

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