Coated VICRYL J571GRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031041332), received between Nov 26, 2018 and Apr 19, 2023 — classified as 2 injuries, 1 malfunction.

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

6 other recalls cover devices cleared under the same FDA submission (K022269, K183183); 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 16, 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.

• InjuryApr 19, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN HALF WITHIN THE EYEBALL WHILE SUTURING THE ORBIT. THE SURGEON WAS UNABLE TO RETRIEVE THE NEEDLE. THE SURGEON SPENT 20-30 MINUTES TO OPENLY DISSECT THE EYE TO LOCATE THE NEEDLE. A MAGNET WAS ATTEMPTED. THE SURGEON WAS UNABLE TO FIND THE NEEDLE. THE PATIENT WAS SENT FOR AN X-RAY ON (B)(6) 2023. THE X-RAY CONFIRMED THE 5MM SUTURE WAS IDENTIFIED IN THE LEFT ORBIT. THERE ARE NO PLANS FOR A FOLLOW UP SURGERY AT THIS TIME. THE PATIENT IS BEING CLOSELY MONITORED. THE PATIENT WAS GIVEN POST OPERATIVE ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16769499 ↗
• MalfunctionSep 28, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO READ THE QR CODE ON THE SUTURE PACKAGING. IT WAS NOTED THAT THE PROBLEM WAS NOT WITH THE READER, BUT IN THE QUALITY OF PRINTING THE QR CODE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499678 ↗
• InjuryNov 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WITHIN SEVEN TO TEN DAYS, THE SUTURE ERODED OUT OF THE EYELID. THE PATIENT EXPERIENCED AN INFLAMMATORY REACTION TO THE SUTURE CAUSING THE TISSUE TO SPIT THE SUTURE AND WOUND DEHISCENCE. THE SURGEON OPINED THAT THERE WAS NOT AN INFECTION, BUT A CHEMICAL REACTION WHICH CAUSED NECROSIS OF THE SKIN MUSCLE AND TARSUS. THE PATIENT WAS TREATED WITH STEROID DROPS. A DIFFERENT PRODUCT WAS USED TO RECLOSE THE AREA. THE CURRENT PATIENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Inflammation; Local Reaction; Necrosis; No Code Available; Wound Dehiscence

  MAUDE report 8102528 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269, K183183. One submission often covers many models, so check the product and lot details in each record.

• Z-1513-2025 · Mar 7, 2025 · Open, Classified
  PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
• Z-0319-2025 · Sep 25, 2024 · Open, Classified
  Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
• 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-2146-2024 · May 10, 2024 · Open, Classified
  PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery.
• 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