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Coated VICRYL VCPB725DRecalls & reported problems

Ethicon, LLC · Antibacterial Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant

All models of Coated VICRYL (350)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Ethicon Coated VICRYL absorbable suture has 120 adverse event reports, with 5 injuries and no deaths. Most describe the suture detaching easily from its needle, and some describe dust, rust-like matter or a missing label in the package. Reports fell from 24 in the prior 12 months to 8 in the last 12 months. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
120
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 10705031056510), received between Feb 28, 2018 and Jun 16, 2026 — classified as 5 injuries, 115 malfunctions.

The most frequently reported specific device problem is “Material Separation” (84 reports).

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); 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.

Reports received per month

Nov 2023: 2 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 3 reportsMar 2024: 1 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 13 reportsJul 2024: 0 reportsAug 2024: 5 reportsSep 2024: 6 reportsOct 2024: 0 reportsNov 2024: 2 reportsDec 2024: 2 reportsJan 2025: 4 reportsFeb 2025: 1 reportsMar 2025: 1 reportsApr 2025: 9 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 3 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 3 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 2 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202613
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Separation84
  • Break19
  • Device Contaminated During Manufacture or Shipping6
  • Adverse Event Without Identified Device or Use Problem3
  • Component Misassembled2
  • Device Markings/Labelling Problem2
  • Appropriate Device Problem Term/Code Not Available1
  • Defective Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions103
  • No Consequences Or Impact To Patient15
  • Fluid Discharge2
  • Erosion1
  • Inflammation1
  • Post Operative Wound Infection1
  • Unspecified Infection1
  • Wound Dehiscence1

Recent adverse event reports

The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 16, 2026Material Separation

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25521298 ↗
  • MalfunctionApr 21, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE EASILY. IT WAS 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 24939871 ↗
  • MalfunctionApr 21, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE EASILY. IT WAS 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 24939867 ↗
  • MalfunctionFeb 23, 2026Device Markings/Labelling Problem

    IT WAS REPORTED THAT PATIENT UNDERWENT OPEN PANCREATICODUODENECTOMY ON (B)(6), 2026, AND SUTURE WAS USED ON THE FASCIA. WHEN THE PRODUCT WAS OPENED BEFORE USE, THE NEEDLE-SUTURE SIZE LABEL INSIDE THE PLASTIC CASE IN THE PACKAGE HAD NOT BEEN ATTACHED. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24417510 ↗
  • MalfunctionFeb 18, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, VCPB725D WAS USED DURING AN ORTHOPEDIC SURGERY CASE INVOLVING A PATIENT WITH SYPHILIS IN THE MORNING. AFTER USING ABOUT FOUR STITCHES, THE DOCTOR NOTICED THAT ONE NEEDLE DID NOT HAVE A SUTURE ATTACHED. THE PRODUCT IS IN THE SOT TRAY. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. PLEASE TAKE PHOTOS FOR JAPANESE CUSTOMER. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24377337 ↗
  • MalfunctionJan 7, 2026Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THERE HAD BEEN A RUST-LIKE FOREIGN MATTER TO THE NEEDLE PART. THE PRODUCT WAS NOT USED, AND ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. IT WAS A CONTROL RELEASE NEEDLE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23996332 ↗
  • MalfunctionJan 5, 2026Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED IT WAS FOUND THAT THERE HAD BEEN DUST IN THE STERILE PACKAGE. THE ALUMINUM PACKAGE HAS BEEN OPENED. THE PRODUCT WAS NOT USED FOR THE PATIENT. IT WAS 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 23958872 ↗
  • MalfunctionJan 5, 2026Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED IT WAS FOUND THAT THERE HAD BEEN DUST IN THE STERILE PACKAGE. THE ALUMINUM PACKAGE HAS BEEN OPENED. THE PRODUCT WAS NOT USED FOR THE PATIENT. IT WAS 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 23958868 ↗
  • MalfunctionOct 16, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE PRODUCT WAS USED FOR THE WOUND CLOSURE. THE CUSTOMER SAID THAT THE SUTURE DETACHED AS SOON AS THEY PICKED UP THE NEEDLE. THIS HAPPENED THREE PACKAGES IN A ROW, SO THEY TOOK OUT ANOTHER PACKAGE AND USED IT. THERE WAS NO EFFECT ON THE SURGERY. THE CUSTOMER HAS TWO BOXES OF THE SAME LOT OF PRODUCT, SO THEY ASKED THE SALES REP TO REPLACE THEM ALL, BUT SINCE THIS IS NOT A VOLUNTARY RECALL PRODUCT, IT WILL BE FIRST PREPARED A REPORT ON THE MALFUNCTION STATUS OF PRODUCTS FROM THE SAME LOT (WHETHER THE SAME EVENT IS BEING OBSERVED), AND THE SALES REP HAS ASKED THEM TO WAIT FOR THE RESULTS AND CONTINUE USING THE PRODUCT AS USUAL UNTIL THEN. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23310588 ↗
  • MalfunctionOct 16, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE PRODUCT WAS USED FOR THE WOUND CLOSURE. THE CUSTOMER SAID THAT THE SUTURE DETACHED AS SOON AS THEY PICKED UP THE NEEDLE. THIS HAPPENED THREE PACKAGES IN A ROW, SO THEY TOOK OUT ANOTHER PACKAGE AND USED IT. THERE WAS NO EFFECT ON THE SURGERY. THE CUSTOMER HAS TWO BOXES OF THE SAME LOT OF PRODUCT, SO THEY ASKED THE SALES REP TO REPLACE THEM ALL, BUT SINCE THIS IS NOT A VOLUNTARY RECALL PRODUCT, IT WILL BE FIRST PREPARED A REPORT ON THE MALFUNCTION STATUS OF PRODUCTS FROM THE SAME LOT (WHETHER THE SAME EVENT IS BEING OBSERVED), AND THE SALES REP HAS ASKED THEM TO WAIT FOR THE RESULTS AND CONTINUE USING THE PRODUCT AS USUAL UNTIL THEN. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23310582 ↗
  • MalfunctionOct 16, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE PRODUCT WAS USED FOR THE WOUND CLOSURE. THE CUSTOMER SAID THAT THE SUTURE DETACHED AS SOON AS THEY PICKED UP THE NEEDLE. THIS HAPPENED THREE PACKAGES IN A ROW, SO THEY TOOK OUT ANOTHER PACKAGE AND USED IT. THERE WAS NO EFFECT ON THE SURGERY. THE CUSTOMER HAS TWO BOXES OF THE SAME LOT OF PRODUCT, SO THEY ASKED THE SALES REP TO REPLACE THEM ALL, BUT SINCE THIS IS NOT A VOLUNTARY RECALL PRODUCT, IT WILL BE FIRST PREPARED A REPORT ON THE MALFUNCTION STATUS OF PRODUCTS FROM THE SAME LOT (WHETHER THE SAME EVENT IS BEING OBSERVED), AND THE SALES REP HAS ASKED THEM TO WAIT FOR THE RESULTS AND CONTINUE USING THE PRODUCT AS USUAL UNTIL THEN. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23310581 ↗
  • MalfunctionJul 2, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. SOME NEEDLES WERE USED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. MOST OF THE PRODUCT WAS USED BUT THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE AND COULD NOT BE SUTURED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22382935 ↗
  • MalfunctionMay 29, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED, DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE IMMEDIATELY WHEN THE NURSE HELD THE NEEDLE WITH THE NEEDLE-HOLDER DURING WOUND CLOSURE. EVEN THOUGH THE NURSE CONTINUED TO USE THE SUTURE, BUT THE SUTURE WAS DETACHED FROM THE NEEDLE MORE EASILY THAN USUAL. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22108003 ↗
  • MalfunctionApr 25, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED, DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE IMMEDIATELY WHEN THE NURSE HELD THE NEEDLE WITH THE NEEDLE-HOLDER DURING WOUND CLOSURE. EVEN THOUGH THE NURSE CONTINUED TO USE THE SUTURE, BUT THE SUTURE WAS DETACHED FROM THE NEEDLE MORE EASILY THAN USUAL. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21909232 ↗
  • MalfunctionApr 17, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY. IT WAS 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 21862777 ↗
  • MalfunctionApr 17, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY. IT WAS 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 21862774 ↗
  • MalfunctionApr 17, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY. IT WAS 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 21862773 ↗
  • MalfunctionApr 17, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY. IT WAS 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 21862758 ↗
  • MalfunctionApr 17, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY. IT WAS 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 21862756 ↗
  • MalfunctionApr 17, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY. IT WAS 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 21862751 ↗
  • MalfunctionApr 2, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. WHEN OPEN THE PACKAGE, THE SUTURE ON NO.1 WAS ALREADY DETACHED. SOME OF THE SUTURES WERE QUICKLY DETACHED DURING USE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21752401 ↗
  • MalfunctionApr 2, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. WHEN OPEN THE PACKAGE, THE SUTURE ON NO.1 WAS ALREADY DETACHED. SOME OF THE SUTURES WERE QUICKLY DETACHED DURING USE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21752368 ↗
  • MalfunctionMar 12, 2025Material Separation; Material Separation

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21587371 ↗
  • MalfunctionFeb 5, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE JAN CODE WAS DIFFERENT FROM THE NOTED IN THE PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21317157 ↗
  • MalfunctionJan 29, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS DETACHED EASILY. IT WAS A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21265468 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

  • Z-2145-2024 · May 10, 2024 · Open, Classified
    VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
  • Z-1310-2009 · Feb 2, 2009 · Terminated
    Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and

Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices

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Sources and updates

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