Coated VICRYL J110TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031037977), received between Mar 30, 2018 and Aug 22, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K022269); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN APPENDICITIS SURGERY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN DURING THE SURGERY. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923149 ↗
• InjuryMar 30, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT PROPHYLACTIC BILATERAL MASTECTOMY ON (B)(6) 2018 AND SUTURE WAS USED. THE PATIENT RETURNED TO PRIMARY PHYSICIAN ON UNKNOWN DATE WITH ALLERGIC REACTION AND WAS PLACED ON ANTIBIOTICS. FOLLOW UP WITH SURGEON ON (B)(6) 2018 AND WAS DIAGNOSED WITH WOUND INFECTION WITH SUTURE REMOVAL ON SAME DATE. THE SURGEON OPINED THAT THE SUTURE MIGHT HAVE BEEN THE ISSUE GIVEN THE PATIENTS ALLERGY TO GLUTEN, THE PATIENT CONDITION IS REPORTED AS FINE WITH NO OTHER ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Not Applicable; Post Operative Wound Infection

  MAUDE report 7386983 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269. One submission often covers many models, so check the product and lot details in each record.

• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc