Coated VICRYL J576GRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031041387), received between Feb 12, 2020 and Apr 2, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYPOSPADIAS PROCEDURE (B)(6) 2021 AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE WAS POPPING OFF MULTIPLE SUTURES. ANOTHER LIKE DEVICE OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609635 ↗
• MalfunctionFeb 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN EYE PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURE WAS USED TO CLOSE THE INCISION USING AN INTERRUPTED LOOP. THE SUTURE WAS LOADED ON THE NEEDLE DRIVER, PASSED TO THE DOCTOR AND AFTER SUTURING, THE NEEDLE DRIVER WAS PASSED TO THE SCRUB TECH AND IT WAS NOTICED THE NEEDLE HAS SEPARATED FROM THE SUTURE AND FALLEN AWAY FROM THE PATIENT, ON THE FLOOR. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9702444 ↗
• MalfunctionFeb 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN EYE PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS LOADED ON THE NEEDLE DRIVER, PASSED TO THE DOCTOR AND AFTER SUTURING, THE NEEDLE DRIVER WAS PASSED TO THE SCRUB TECH AND IT WAS NOTICED THE NEEDLE HAS SEPARATED FROM THE SUTURE AND FALLEN AWAY FROM THE PATIENT. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9702415 ↗
• MalfunctionFeb 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN EYE PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURE WAS LOADED ON THE NEEDLE DRIVER, PASSED TO THE DOCTOR AND AFTER SUTURING, THE NEEDLE DRIVER WAS PASSED TO THE SCRUB TECH AND IT WAS NOTICED THE NEEDLE HAS SEPARATED FROM THE SUTURE AND FALLEN AWAY FROM THE PATIENT, ON THE STERILE DRAPE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9702235 ↗
• MalfunctionFeb 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN EYE PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURE WAS LOADED ON THE NEEDLE DRIVER, PASSED TO THE DOCTOR AND AFTER SUTURING, THE NEEDLE DRIVER WAS PASSED TO THE SCRUB TECH AND IT WAS NOTICED THE NEEDLE HAS SEPARATED FROM THE SUTURE AND FALLEN AWAY FROM THE PATIENT, ON THE STERILE DRAPE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9702151 ↗

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