Coated VICRYL VCP311H (UDI 10705031052192)Recalls & reported problems

Summary

The FDA's MAUDE database contains 252 adverse event reports that list this exact device (DI 10705031052192), received between Dec 12, 2018 and Sep 28, 2026 — classified as 21 injuries, 231 malfunctions.

The most frequently reported specific device problem is “Break” (120 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 252 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923215 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904877 ↗
• MalfunctionMar 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6)2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SURGEON WANT SUTURE WOUND , NEEDLE ISOLATE FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561318 ↗
• MalfunctionJan 13, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY DUE TO APPENDICITIS ON (B)(6) 2025 AND SUTURE WAS USED. 682 DAYS LATER, THE PATIENT FOUND THAT THE SUTURE WAS DISCHARGED FROM THE BODY, CAUSING REDNESS, SWELLING, AND INFLAMMATION. AFTER INVESTIGATION, IT WAS FOUND THAT THE SUTURE USED DURING THE SURGICAL CLOSURE WAS NOT ABSORBED AND WAS EXCRETED. THE SUTURE HAS BEEN TAKEN OUT FOR THE PATIENT AND NO OTHER ISSUES HAVE BEEN FOUND. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Erythema; Inflammation; Pocket Erosion; Swelling/ Edema

  MAUDE report 24060611 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHEN SUTURING THE WOUND, THE NEEDLE BROKE IN HALF OUTSIDE THE BODY, CAUSING THE SUTURE TO BE INTERRUPTED, DELAYING THE SURGICAL PROCESS, AND INCREASING THE SURGICAL DURATION. THE DOCTOR IMMEDIATELY STOPPED USING IT AND REPLACED THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829566 ↗
• InjuryNov 24, 2025Failure to Degrade; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT REMOVAL SURGERY OF NASAL WING NEVUS ON (B)(6) 2025 AND SUTURE WAS USED AS THE INTERNAL SUTURE AND THE SURGICAL PROCESS WENT SMOOTHLY. SUBSEQUENTLY, THE PATIENT CAME TO THE HOSPITAL 7 DAYS LATER TO HAVE THE STITCHES REMOVED. THEN, 36 DAYS AFTER SURGERY, THE PATIENT CAME TO THE HOSPITAL FOR A FOLLOW-UP VISIT DUE TO INFLAMMATION AND POOR HEALING OF THE SURGICAL INCISION. IT WAS FOUND THAT THE SURGICAL INCISION INFLAMMATION WAS CAUSED BY EFFLUX DUE TO MALABSORPTION OF THE INTERNAL SUTURE, AND THE TREATMENT MEASURES WERE AS FOLLOWS: 1. DISINFECTION AND CLEANING OF THE SURGICAL INCISION, CUTTING OFF THE SUTURE HEAD OF THE EFFLUX; 2. RED LIGHT IRRADIATION OF THE WOUND; 3. PRESCRIPTION OF COMPOUND PHELLODENDRON LIQUID COATING AND EXTERNAL APPLICATION OF HUMAN EPIDERMAL GROWTH FACTOR FOR EXTERNAL USE. AFTER 14 DAYS, THE PATIENT CAME BACK TO THE HOSPITAL AGAIN FOR RETURN VISIT. THE EXAMINATION FOUND THAT THE SURGICAL INCISION WAS STILL NOT HEALED, AND THERE WAS INTERNAL SUTURE EFFLUX. TREATMENT MEASURES: 1. DISINFECT AND CLEAN THE SURGICAL INCISION, CUT OFF THE SUTURE HEAD OF THE EFFLUX; 2. CONTINUE TO USE TOPICAL COMPOUND PHELLODENDRON LIQUID COATING

  Patient problems: Impaired Healing; Inflammation; Pocket Erosion

  MAUDE report 23633890 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT ENTERED THE OPERATING ROOM FOR SURGERY AT 08:10. WHEN THE SURGERY WAS ABOUT 11:55, WHEN THE DOCTOR SEWED THE LAST INCISION WITH SUTURE AND TOOK OUT THE NEEDLE, IT WAS FOUND THAT ONLY ONE SECTION OF THE NEEDLE WAS LEFT AND ANOTHER SECTION WAS MISSING. THEREFORE, THE EMERGENCY SYSTEM WAS STARTED, AND THE STAFF IN THE OPERATING ROOM HELPED TO FIND THE BROKEN NEEDLE. AT 12:20, THE NURSE FOUND THE BROKEN NEEDLE ON THE GROUND AND CONFIRMED THAT IT WAS THE ONE TO BE SEARCHED FOR AFTER MATCHING WITH THE OTHER CUTTING END. SO, THE SURGERY CONTINUED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619112 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 12:28, THE PATIENT GAVE BIRTH TO A LIVE MALE INFANT WITH AN I ° PERINEAL LACERATION. THE MIDWIFE SEWED UP THE WOUND WITH SUTURE. WHEN SEWING THE LAST STITCH AND TYING THE THIRD KNOT, THE END OF THE SUTURE CLAMPED BY THE NEEDLE HOLDER NATURALLY BROKE. THE MIDWIFE TOOK OUT THE RESIDUAL SUTURE AND CHECKED THAT THE KNOT WAS NOT LOOSE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490686 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PRODUCT WAS EASILY CUT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488714 ↗
• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC OVARIAN CYSTECTOMY PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER USING SUTURE TO SUTURE OVARIAN TISSUE DURING SURGERY, THE NEEDLE BROKE AT THE TAIL ONE-THIRD AND WAS IMMEDIATELY REMOVED FROM THE ABDOMINAL CAVITY BY THE DOCTOR. STOP USING AND REPLACE WITH OTHER SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23058378 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAPP PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL (B)(4) PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. THERE WILL RETURN (B)(4) REPRESENTATIVE SAMPLES FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532806 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAPP PROCEDURE ON 15-06-2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. THERE WILL RETURN 38 REPRESENTATIVE SAMPLES FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532804 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAPP PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. THERE WILL RETURN 38 REPRESENTATIVE SAMPLES FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532803 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAPP PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. THERE WILL RETURN 38 REPRESENTATIVE SAMPLES FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532801 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAPP PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL (B)(4) PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. THERE WILL RETURN (B)(4) REPRESENTATIVE SAMPLES FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532800 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TITLE: EFFECT OF DIFFERENT REINFORCEMENT METHODS OF ESOPHAGOJEJUNOSTOMY IN LAPAROSCOPIC-ASSISTED TOTAL GASTRECTOMY. THE AIM OF THIS STUDY IS TO COMPARE THE EFFECTS OF DIFFERENT ESOPHAGOJEJUNOSTOMY REINFORCEMENT METHODS IN LAPAROSCOPIC-ASSISTED TOTAL GASTRECTOMY. BETWEEN JANUARY 2020 TO NOVEMBER 2022, 100 PATIENTS WITH GASTRIC CANCER RECEIVED LAPAROSCOPIC-ASSISTED TOTAL GASTRECTOMY IN PEOPLE'S HOSPITAL. INCLUSION CRITERIA (1) GASTRIC CANCER IN ACCORDANCE WITH THE "INTERNAL MEDICINE". THEY WERE DIVIDED INTO GROUP B (N = 50) AND GROUP A (N = 50) ACCORDING TO THE RANDOM NUMBER TABLE. IN GROUP A, THERE WERE 31 MALES AND 19 FEMALES, AGED 52 ~ 67 YEARS, WITH MEAN ONE OF (61.34 PLUS OR MINUS 3.09) YEARS; STAGING OF GASTRIC CANCER: 21 CASES OF STAGE II, 29 CASES OF STAGE III; BODY MASS INDEX OF 19 ~ 21 KG/M2, WITH MEAN BODY MASS INDEX (20.02 PLUS OR MINUS 0.39) KG/M2. IN GROUP B, THERE WERE 28 MALES AND 22 FEMALES, AGED 51 ~ 68 YEARS, WITH MEAN ONE OF (61.42 PLUS OR MINUS 3.12) YEARS; GASTRIC CANCER STAGES: 22 CASES IN STAGE II AND 28 CASES IN STAGE III; BODY MASS INDEX OF 19 - 21 KG/M2, WITH MEAN BODY MASS INDEX OF (20.14 PLUS OR MINUS 0.35) KG/M2. LAPAROSCOPY-ASSISTED TOTAL GASTRECTOMY IN

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 22514307 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORAL PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE BREAKAGE AFTER 3 PASSES IN ORAL CAVITY SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365223 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORAL PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE BREAKAGE AFTER 3 PASSES IN ORAL CAVITY SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365221 ↗
• MalfunctionJun 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND SUTURING PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. AT 11:00, THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT DUE TO "CRANIOCEREBRAL TRAUMA". THE DOCTOR IMMEDIATELY PERFORMED SURGERY ON THE PATIENT, AND THE SURGICAL PROCESS WENT SMOOTHLY. THE DOCTOR FOLLOWED THE STANDARD PROCEDURES AND USED SUTURE TO SUTURE THE WOUND. HOWEVER, THE NEEDLE TIP BROKE DURING THE SUTURE PROCESS, AND THE SAME BATCH NUMBER OF SUTURE WAS REPLACED TO CONTINUE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289197 ↗
• MalfunctionJun 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THREAD COMES LOOSE/BREAKS WHEN PASSING THROUGH TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22188653 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012941 ↗
• MalfunctionMay 9, 2025Break; Product Quality Problem; Material Separation; Break; Product Quality Problem; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE ORTHOPAEDIC SURGEON MENTIONED THAT THERE ARE 3 SUTURES THAT BROKE WHEN HE WAS DOING THE SUTURING. THE NEEDLE DETACHED FROM THE SWAGE, AND THE SUTURE THAT HE HAD TIED OPENED ON ITS OWN AND BEFORE NOT SECURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994993 ↗
• MalfunctionMay 9, 2025Break; Product Quality Problem; Material Separation; Break; Product Quality Problem; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE ORTHOPAEDIC SURGEON MENTIONED THAT THERE IS 3 SUTURES THAT BROKE WHEN HE WAS DOING THE SUTURING. THE NEEDLE DETACHED FROM THE SWAGE, AND THE SUTURE THAT HE HAD TIED OPENED ON ITS OWN AND BEFORE NOT SECURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994990 ↗
• MalfunctionMay 9, 2025Break; Product Quality Problem; Material Separation; Break; Product Quality Problem; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE ORTHOPAEDIC SURGEON MENTIONED THAT THERE ARE 3 SUTURES THAT BROKE WHEN HE WAS DOING THE SUTURING. THE NEEDLE DETACHED FROM THE SWAGE, AND THE SUTURE THAT HE HAD TIED OPENED ON ITS OWN AND BEFORE NOT SECURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994988 ↗
• MalfunctionApr 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING THE TISSUE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE SURGEON CHECKED THE INTEGRITY OF THE NEEDLE AND REPLACED IT WITH A NEW SUTURE TO CONTINUE SUTURING THE INCISION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21772999 ↗

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