Coated VICRYL J480HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031040359), received between Nov 30, 2022 and Apr 13, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE USING THE DEVICE ON THE PATIENT, IT POPPED OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16733832 ↗
• MalfunctionApr 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE USING THE DEVICE ON THE PATIENT, IT POPPED OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16733828 ↗
• MalfunctionDec 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS COMING OFF THE SUTURE EASILY WHILE SUTURING UNKNOWN TISSUE. ANOTHER LIKE DEVICE OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15962544 ↗
• MalfunctionNov 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC JOINT REPLACEMENT PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, OVER THE PAST TWO WEEKS THE FACILITY HAS BEEN HAVING ISSUE WITH THE NEEDLE POPPING OFF THE SUTURE WHILE SUTURING UNKNOWN TISSUE. THE NEEDLE WAS NEVER OUT OF THE CONTROL OF THE SURGEON. ANOTHER LIKE DEVICE 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 15889381 ↗
• MalfunctionNov 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC JOINT REPLACEMENT PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, OVER THE PAST TWO WEEKS THE FACILITY HAS BEEN HAVING ISSUE WITH THE NEEDLE POPPING OFF THE SUTURE WHILE SUTURING UNKNOWN TISSUE. THE NEEDLE WAS NEVER OUT OF THE CONTROL OF THE SURGEON. ANOTHER LIKE DEVICE 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 15889205 ↗
• MalfunctionNov 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC JOINT REPLACEMENT PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, OVER THE PAST TWO WEEKS THE FACILITY HAS BEEN HAVING ISSUE WITH THE NEEDLE POPPING OFF THE SUTURE WHILE SUTURING UNKNOWN TISSUE. THE NEEDLE WAS NEVER OUT OF THE CONTROL OF THE SURGEON. ANOTHER LIKE DEVICE 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 15889108 ↗
• MalfunctionNov 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC JOINT REPLACEMENT PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, OVER THE PAST TWO WEEKS THE FACILITY HAS BEEN HAVING ISSUE WITH THE NEEDLE POPPING OFF THE SUTURE WHILE SUTURING UNKNOWN TISSUE. THE NEEDLE WAS NEVER OUT OF THE CONTROL OF THE SURGEON. ANOTHER LIKE DEVICE 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 15888514 ↗
• MalfunctionNov 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC JOINT REPLACEMENT PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, OVER THE PAST TWO WEEKS THE FACILITY HAS BEEN HAVING ISSUE WITH THE NEEDLE POPPING OFF THE SUTURE WHILE SUTURING UNKNOWN TISSUE. THE NEEDLE WAS NEVER OUT OF THE CONTROL OF THE SURGEON. ANOTHER LIKE DEVICE 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 15888425 ↗
• MalfunctionNov 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC JOINT REPLACEMENT PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, OVER THE PAST TWO WEEKS THE FACILITY HAS BEEN HAVING ISSUE WITH THE NEEDLE POPPING OFF THE SUTURE WHILE SUTURING UNKNOWN TISSUE. THE NEEDLE WAS NEVER OUT OF THE CONTROL OF THE SURGEON. ANOTHER LIKE DEVICE 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 15888372 ↗

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