Coated VICRYL J683HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031042193), received between Mar 2, 2021 and Mar 2, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401801 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401800 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401795 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401786 ↗

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-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-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