Coated VICRYL J495GRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10705031040557), received between Oct 14, 2020 and Dec 31, 2025 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Material Separation” (40 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PATIENT¿S OPERATING DAY, THEY HAD AN ISSUE WITH A SUTURE. SHE HAD TO USE 3 PACKS BECAUSE THE THREAD KEPT BREAKING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934782 ↗
• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PATIENT¿S OPERATING DAY, THEY HAD AN ISSUE WITH A SUTURE. SHE HAD TO USE 3 PACKS BECAUSE THE THREAD KEPT BREAKING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934775 ↗
• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PATIENT¿S OPERATING DAY, THEY HAD AN ISSUE WITH A SUTURE. SHE HAD TO USE 3 PACKS BECAUSE THE THREAD KEPT BREAKING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934770 ↗
• MalfunctionJun 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT ED STAFF NOTIFIED THAT TWO SETS OF 5-0 VICRYL SUTURES HAD ISSUES WHERE THE NEEDLE IMMEDIATELY BROKE AWAY FROM THE SUTURE. BOTH DEVICES WERE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22300606 ↗
• MalfunctionJun 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT ED STAFF NOTIFIED THAT TWO SETS OF 5-0 VICRYL SUTURES HAD ISSUES WHERE THE NEEDLE IMMEDIATELY BROKE AWAY FROM THE SUTURE. BOTH DEVICES WERE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22300596 ↗
• MalfunctionJan 13, 2025Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN ENT PROCEDURE THAT THE SUTURE BROKE AND THE NEEDLE WAS NOT PERFORMING NORMALLY. ANOTHER LIKE DEVICE OF A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. SURGEON STATED HE HAS BEEN HAVING THIS ISSUE FOR A FEW CASES NOW. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139345 ↗
• MalfunctionJan 13, 2025Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN ENT PROCEDURE THAT THE SUTURE BROKE AND THE NEEDLE WAS NOT PERFORMING NORMALLY. ANOTHER LIKE DEVICE OF A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. SURGEON STATED HE HAS BEEN HAVING THIS ISSUE FOR A FEW CASES NOW. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139337 ↗
• MalfunctionJan 13, 2025Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN ENT PROCEDURE THAT THE SUTURE BROKE AND THE NEEDLE WAS NOT PERFORMING NORMALLY. ANOTHER LIKE DEVICE OF A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. SURGEON STATED HE HAS BEEN HAVING THIS ISSUE FOR A FEW CASES NOW. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139327 ↗
• MalfunctionJan 13, 2025Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN ENT PROCEDURE THAT THE SUTURE BROKE AND THE NEEDLE WAS NOT PERFORMING NORMALLY. ANOTHER LIKE DEVICE OF A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. SURGEON STATED HE HAS BEEN HAVING THIS ISSUE FOR A FEW CASES NOW. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139326 ↗
• MalfunctionApr 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THE ACCOUNT: THE CUSTOMER STATES THEY HAVE ORDERED THIS ITEM ON SEVERAL ORDERS AND HAVE FOUND THAT THE SUTURE DOES NOT STAY ATTACHED TO THE NEEDLE IT FALLS OFF WITH VERY LITTLE FORCE IF ANY AT ALL THEY BELIEVE THIS IS DEFECTIVE AND THEY HAVE FOUR BOX WITH THIS LOT. CUSTOMER WOULD LIKE REPLACEMENT WITH A DIFFERENT LOT STATING THEY BELIEVE THIS LOT TO BE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19037720 ↗
• MalfunctionApr 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THE ACCOUNT: THE CUSTOMER STATES THEY HAVE ORDERED THIS ITEM ON SEVERAL ORDERS AND HAVE FOUND THAT THE SUTURE DOES NOT STAY ATTACHED TO THE NEEDLE IT FALLS OFF WITH VERY LITTLE FORCE IF ANY AT ALL THEY BELIEVE THIS IS DEFECTIVE AND THEY HAVE FOUR BOX WITH THIS LOT. CUSTOMER WOULD LIKE REPLACEMENT WITH A DIFFERENT LOT STATING THEY BELIEVE THIS LOT TO BE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19037719 ↗
• MalfunctionMar 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THE ACCOUNT: THE CUSTOMER STATES THEY HAVE ORDERED THIS ITEM ON SEVERAL ORDERS AND HAVE FOUND THAT THE SUTURE DOES NOT STAY ATTACHED TO THE NEEDLE IT FALLS OFF WITH VERY LITTLE FORCE IF ANY AT ALL THEY BELIEVE THIS IS DEFECTIVE AND THEY HAVE FOUR BOX WITH THIS LOT. CUSTOMER WOULD LIKE REPLACEMENT WITH A DIFFERENT LOT STATING THEY BELIEVE THIS LOT TO BE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935814 ↗
• MalfunctionMar 11, 2024Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL/ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS UNRAVELING AND DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18875383 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT DR. HARRINGTON HAS HAD A PROBLEM WITH THE J495 5-0 SUTURE THAT SHE USES FOR SOME OF HER PROCEDURES. THE NEEDLE HAS POPPED OFF A NUMBER OF TIMES.THEY HAVE TRIED DIFFERENT LOT NUMBERS WITH NO FIX. THEY PULLED OUT ONE EACH OF THE J495, A 4-0 J496 AND A 6-0 J492 AND TESTED THEM BY PULLING ON THE SUTURE UNTIL NEEDLE POP OFF. THERE WAS A SIGNIFICANT EASE OF POP OFF WITH THIS 5-0 THAN THE OTHER TWO SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841569 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT DR. HARRINGTON HAS HAD A PROBLEM WITH THE J495 5-0 SUTURE THAT SHE USES FOR SOME OF HER PROCEDURES. THE NEEDLE HAS POPPED OFF A NUMBER OF TIMES. THEY HAVE TRIED DIFFERENT LOT NUMBERS WITH NO FIX. THEY PULLED OUT ONE EACH OF THE J495, A 4-0 J496 AND A 6-0 J492 AND TESTED THEM BY PULLING ON THE SUTURE UNTIL NEEDLE POP OFF. THERE WAS A SIGNIFICANT EASE OF POP OFF WITH THIS 5-0 THAN THE OTHER TWO SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841300 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT DR. HARRINGTON HAS HAD A PROBLEM WITH THE J495 5-0 SUTURE THAT SHE USES FOR SOME OF HER PROCEDURES. THE NEEDLE HAS POPPED OFF A NUMBER OF TIMES. THEY HAVE TRIED DIFFERENT LOT NUMBERS WITH NO FIX. THEY PULLED OUT ONE EACH OF THE J495, A 4-0 J496 AND A 6-0 J492 AND TESTED THEM BY PULLING ON THE SUTURE UNTIL NEEDLE POP OFF. THERE WAS A SIGNIFICANT EASE OF POP OFF WITH THIS 5-0 THAN THE OTHER TWO SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841299 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT DR. (B)(6) HAS HAD A PROBLEM WITH THE J495 5-0 SUTURE THAT SHE USES FOR SOME OF HER PROCEDURES. THE NEEDLE HAS POPPED OFF A NUMBER OF TIMES. THEY HAVE TRIED DIFFERENT LOT NUMBERS WITH NO FIX. THEY PULLED OUT ONE EACH OF THE J495, A 4-0 J496 AND A 6-0 J492 AND TESTED THEM BY PULLING ON THE SUTURE UNTIL NEEDLE POP OFF. THERE WAS A SIGNIFICANT EASE OF POP OFF WITH THIS 5-0 THAN THE OTHER TWO SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841298 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT DR. HARRINGTON HAS HAD A PROBLEM WITH THE J495 5-0 SUTURE THAT SHE USES FOR SOME OF HER PROCEDURES. THE NEEDLE HAS POPPED OFF A NUMBER OF TIMES.THEY HAVE TRIED DIFFERENT LOT NUMBERS WITH NO FIX. THEY PULLED OUT ONE EACH OF THE J495, A 4-0 J496 AND A 6-0 J492 AND TESTED THEM BY PULLING ON THE SUTURE UNTIL NEEDLE POP OFF. THERE WAS A SIGNIFICANT EASE OF POP OFF WITH THIS 5-0 THAN THE OTHER TWO SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841198 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT DR. HARRINGTON HAS HAD A PROBLEM WITH THE J495 5-0 SUTURE THAT SHE USES FOR SOME OF HER PROCEDURES. THE NEEDLE HAS POPPED OFF A NUMBER OF TIMES.THEY HAVE TRIED DIFFERENT LOT NUMBERS WITH NO FIX. THEY PULLED OUT ONE EACH OF THE J495, A 4-0 J496 AND A 6-0 J492 AND TESTED THEM BY PULLING ON THE SUTURE UNTIL NEEDLE POP OFF. THERE WAS A SIGNIFICANT EASE OF POP OFF WITH THIS 5-0 THAN THE OTHER TWO SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841197 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT DR. (B)(6) HAS HAD A PROBLEM WITH THE J495 5-0 SUTURE THAT SHE USES FOR SOME OF HER PROCEDURES. THE NEEDLE HAS POPPED OFF A NUMBER OF TIMES.THEY HAVE TRIED DIFFERENT LOT NUMBERS WITH NO FIX. THEY PULLED OUT ONE EACH OF THE J495, A 4-0 J496 AND A 6-0 J492 AND TESTED THEM BY PULLING ON THE SUTURE UNTIL NEEDLE POP OFF. THERE WAS A SIGNIFICANT EASE OF POP OFF WITH THIS 5-0 THAN THE OTHER TWO SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841196 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT DR. (B)(6) HAS HAD A PROBLEM WITH THE J495 5-0 SUTURE THAT SHE USES FOR SOME OF HER PROCEDURES. THE NEEDLE HAS POPPED OFF A NUMBER OF TIMES. THEY HAVE TRIED DIFFERENT LOT NUMBERS WITH NO FIX. THEY PULLED OUT ONE EACH OF THE J495, A 4-0 J496 AND A 6-0 J492 AND TESTED THEM BY PULLING ON THE SUTURE UNTIL NEEDLE POP OFF. THERE WAS A SIGNIFICANT EASE OF POP OFF WITH THIS 5-0 THAN THE OTHER TWO SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841036 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT DR. HARRINGTON HAS HAD A PROBLEM WITH THE J495 5-0 SUTURE THAT SHE USES FOR SOME OF HER PROCEDURES. THE NEEDLE HAS POPPED OFF A NUMBER OF TIMES.THEY HAVE TRIED DIFFERENT LOT NUMBERS WITH NO FIX. THEY PULLED OUT ONE EACH OF THE J495, A 4-0 J496 AND A 6-0 J492 AND TESTED THEM BY PULLING ON THE SUTURE UNTIL NEEDLE POP OFF. THERE WAS A SIGNIFICANT EASE OF POP OFF WITH THIS 5-0 THAN THE OTHER TWO SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841020 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT DR. HARRINGTON HAS HAD A PROBLEM WITH THE J495 5-0 SUTURE THAT SHE USES FOR SOME OF HER PROCEDURES. THE NEEDLE HAS POPPED OFF A NUMBER OF TIMES. THEY HAVE TRIED DIFFERENT LOT NUMBERS WITH NO FIX. THEY PULLED OUT ONE EACH OF THE J495, A 4-0 J496 AND A 6-0 J492 AND TESTED THEM BY PULLING ON THE SUTURE UNTIL NEEDLE POP OFF. THERE WAS A SIGNIFICANT EASE OF POP OFF WITH THIS 5-0 THAN THE OTHER TWO SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841015 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT DR. (B)(6) HAS HAD A PROBLEM WITH THE J495 5-0 SUTURE THAT SHE USES FOR SOME OF HER PROCEDURES. THE NEEDLE HAS POPPED OFF A NUMBER OF TIMES.THEY HAVE TRIED DIFFERENT LOT NUMBERS WITH NO FIX. THEY PULLED OUT ONE EACH OF THE J495, A 4-0 J496 AND A 6-0 J492 AND TESTED THEM BY PULLING ON THE SUTURE UNTIL NEEDLE POP OFF. THERE WAS A SIGNIFICANT EASE OF POP OFF WITH THIS 5-0 THAN THE OTHER TWO SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18840764 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT DR. HARRINGTON HAS HAD A PROBLEM WITH THE J495 5-0 SUTURE THAT SHE USES FOR SOME OF HER PROCEDURES. THE NEEDLE HAS POPPED OFF A NUMBER OF TIMES. THEY HAVE TRIED DIFFERENT LOT NUMBERS WITH NO FIX. THEY PULLED OUT ONE EACH OF THE J495, A 4-0 J496 AND A 6-0 J492 AND TESTED THEM BY PULLING ON THE SUTURE UNTIL NEEDLE POP OFF. THERE WAS A SIGNIFICANT EASE OF POP OFF WITH THIS 5-0 THAN THE OTHER TWO SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18840738 ↗

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