Coated VICRYL J506GRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705031040755), received between Nov 30, 2021 and Aug 21, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN FRAYED, THE SUTURE WAS BROKEN AND THERE WERE CONCERNS ABOUT THE TENSILE STRENGTH DUE TO ABSORBABLE SUTURES. ALTHOUGH THEY HAVE USED A LARGE AMOUNT UNTIL NOW, BUT THEY THINK THAT THESE PRODUCTS ARE DEFECTIVE. THE SAME EVENTS CONTINUED WHEN THE PACKAGE WAS OPENED, SO THE CUSTOMER REQUESTS AN EXCHANGE AND INVESTIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22867395 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN FRAYED, THE SUTURE WAS BROKEN AND THERE WERE CONCERNS ABOUT THE TENSILE STRENGTH DUE TO ABSORBABLE SUTURES. ALTHOUGH THEY HAVE USED A LARGE AMOUNT UNTIL NOW, BUT THEY THINK THAT THESE PRODUCTS ARE DEFECTIVE. THE SAME EVENTS CONTINUED WHEN THE PACKAGE WAS OPENED, SO THE CUSTOMER REQUESTS AN EXCHANGE AND INVESTIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22867390 ↗
• MalfunctionAug 21, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN FRAYED, THE SUTURE WAS BROKEN AND THERE WERE CONCERNS ABOUT THE TENSILE STRENGTH DUE TO ABSORBABLE SUTURES. ALTHOUGH THEY HAVE USED A LARGE AMOUNT UNTIL NOW, BUT THEY THINK THAT THESE PRODUCTS ARE DEFECTIVE. THE SAME EVENTS CONTINUED WHEN THE PACKAGE WAS OPENED, SO THE CUSTOMER REQUESTS AN EXCHANGE AND INVESTIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865195 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN FRAYED, THE SUTURE WAS BROKEN AND THERE WERE CONCERNS ABOUT THE TENSILE STRENGTH DUE TO ABSORBABLE SUTURES. ALTHOUGH THEY HAVE USED A LARGE AMOUNT UNTIL NOW, BUT THEY THINK THAT THESE PRODUCTS ARE DEFECTIVE. THE SAME EVENTS CONTINUED WHEN THE PACKAGE WAS OPENED, SO THE CUSTOMER REQUESTS AN EXCHANGE AND INVESTIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862959 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN FRAYED, THE SUTURE WAS BROKEN AND THERE WERE CONCERNS ABOUT THE TENSILE STRENGTH DUE TO ABSORBABLE SUTURES. ALTHOUGH THEY HAVE USED A LARGE AMOUNT UNTIL NOW, BUT THEY THINK THAT THESE PRODUCTS ARE DEFECTIVE. THE SAME EVENTS CONTINUED WHEN THE PACKAGE WAS OPENED, SO THE CUSTOMER REQUESTS AN EXCHANGE AND INVESTIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862955 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN FRAYED, THE SUTURE WAS BROKEN AND THERE WERE CONCERNS ABOUT THE TENSILE STRENGTH DUE TO ABSORBABLE SUTURES. ALTHOUGH THEY HAVE USED A LARGE AMOUNT UNTIL NOW, BUT THEY THINK THAT THESE PRODUCTS ARE DEFECTIVE. THE SAME EVENTS CONTINUED WHEN THE PACKAGE WAS OPENED, SO THE CUSTOMER REQUESTS AN EXCHANGE AND INVESTIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862038 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN FRAYED, THE SUTURE WAS BROKEN AND THERE WERE CONCERNS ABOUT THE TENSILE STRENGTH DUE TO ABSORBABLE SUTURES. ALTHOUGH THEY HAVE USED A LARGE AMOUNT UNTIL NOW, BUT THEY THINK THAT THESE PRODUCTS ARE DEFECTIVE. THE SAME EVENTS CONTINUED WHEN THE PACKAGE WAS OPENED, SO THE CUSTOMER REQUESTS AN EXCHANGE AND INVESTIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862037 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN FRAYED, THE SUTURE WAS BROKEN AND THERE WERE CONCERNS ABOUT THE TENSILE STRENGTH DUE TO ABSORBABLE SUTURES. ALTHOUGH THEY HAVE USED A LARGE AMOUNT UNTIL NOW, BUT THEY THINK THAT THESE PRODUCTS ARE DEFECTIVE. THE SAME EVENTS CONTINUED WHEN THE PACKAGE WAS OPENED, SO THE CUSTOMER REQUESTS AN EXCHANGE AND INVESTIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862026 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN FRAYED, THE SUTURE WAS BROKEN AND THERE WERE CONCERNS ABOUT THE TENSILE STRENGTH DUE TO ABSORBABLE SUTURES. ALTHOUGH THEY HAVE USED A LARGE AMOUNT UNTIL NOW, BUT THEY THINK THAT THESE PRODUCTS ARE DEFECTIVE. THE SAME EVENTS CONTINUED WHEN THE PACKAGE WAS OPENED, SO THE CUSTOMER REQUESTS AN EXCHANGE AND INVESTIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862024 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN FRAYED, THE SUTURE WAS BROKEN AND THERE WERE CONCERNS ABOUT THE TENSILE STRENGTH DUE TO ABSORBABLE SUTURES. ALTHOUGH THEY HAVE USED A LARGE AMOUNT UNTIL NOW, BUT THEY THINK THAT THESE PRODUCTS ARE DEFECTIVE. THE SAME EVENTS CONTINUED WHEN THE PACKAGE WAS OPENED, SO THE CUSTOMER REQUESTS AN EXCHANGE AND INVESTIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861967 ↗
• MalfunctionAug 21, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN FRAYED, THE SUTURE WAS BROKEN AND THERE WERE CONCERNS ABOUT THE TENSILE STRENGTH DUE TO ABSORBABLE SUTURES. ALTHOUGH THEY HAVE USED A LARGE AMOUNT UNTIL NOW, BUT THEY THINK THAT THESE PRODUCTS ARE DEFECTIVE. THE SAME EVENTS CONTINUED WHEN THE PACKAGE WAS OPENED, SO THE CUSTOMER REQUESTS AN EXCHANGE AND INVESTIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861959 ↗
• MalfunctionJul 31, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN DENTAL AND ORAL SURGERY, THE SUTURES WERE FRAYED OR BROKEN IN THE MIDDLE, AND SINCE THEY ARE ABSORBENT SUTURES, SO IT WAS CONCERNED ABOUT THEIR TENSILE STRENGTH. THE SAME EVENT HAPPENED IN QUICK SUCCESSION WHEN OPENING THE PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674170 ↗
• MalfunctionJul 31, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN DENTAL AND ORAL SURGERY, THE SUTURES WERE FRAYED OR BROKEN IN THE MIDDLE, AND SINCE THEY ARE ABSORBENT SUTURES, SO IT WAS CONCERNED ABOUT THEIR TENSILE STRENGTH. THE SAME EVENT HAPPENED IN QUICK SUCCESSION WHEN OPENING THE PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674155 ↗
• MalfunctionJul 31, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN DENTAL AND ORAL SURGERY, THE SUTURES WERE FRAYED OR BROKEN IN THE MIDDLE, AND SINCE THEY ARE ABSORBENT SUTURES, SO IT WAS CONCERNED ABOUT THEIR TENSILE STRENGTH. THE SAME EVENT HAPPENED IN QUICK SUCCESSION WHEN OPENING THE PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674148 ↗
• MalfunctionJul 31, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN DENTAL AND ORAL SURGERY, THE SUTURES WERE FRAYED OR BROKEN IN THE MIDDLE, AND SINCE THEY ARE ABSORBENT SUTURES, SO IT WAS CONCERNED ABOUT THEIR TENSILE STRENGTH. THE SAME EVENT HAPPENED IN QUICK SUCCESSION WHEN OPENING THE PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674133 ↗
• MalfunctionJul 31, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN DENTAL AND ORAL SURGERY, THE SUTURES WERE FRAYED OR BROKEN IN THE MIDDLE, AND SINCE THEY ARE ABSORBENT SUTURES, SO IT WAS CONCERNED ABOUT THEIR TENSILE STRENGTH. THE SAME EVENT HAPPENED IN QUICK SUCCESSION WHEN OPENING THE PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674125 ↗
• MalfunctionJul 31, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN DENTAL AND ORAL SURGERY, THE SUTURES WERE FRAYED OR BROKEN IN THE MIDDLE, AND SINCE THEY ARE ABSORBENT SUTURES, SO IT WAS CONCERNED ABOUT THEIR TENSILE STRENGTH. THE SAME EVENT HAPPENED IN QUICK SUCCESSION WHEN OPENING THE PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674110 ↗
• MalfunctionJul 31, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN DENTAL AND ORAL SURGERY, THE SUTURES WERE FRAYED OR BROKEN IN THE MIDDLE, AND SINCE THEY ARE ABSORBENT SUTURES, SO IT WAS CONCERNED ABOUT THEIR TENSILE STRENGTH. THE SAME EVENT HAPPENED IN QUICK SUCCESSION WHEN OPENING THE PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674107 ↗
• MalfunctionJul 31, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN DENTAL AND ORAL SURGERY, THE SUTURES WERE FRAYED OR BROKEN IN THE MIDDLE, AND SINCE THEY ARE ABSORBENT SUTURES, SO IT WAS CONCERNED ABOUT THEIR TENSILE STRENGTH. THE SAME EVENT HAPPENED IN QUICK SUCCESSION WHEN OPENING THE PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674091 ↗
• MalfunctionAug 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BREAKAGE OCCURED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072928 ↗
• MalfunctionAug 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072926 ↗
• MalfunctionDec 30, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118102 ↗
• MalfunctionDec 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019509 ↗
• MalfunctionNov 30, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON (B)(6) , 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12898494 ↗

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