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PROLENE 8833HRecalls & reported problems

Ethicon, LLC · Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Ethicon Prolene 8833H is a blue polypropylene nonabsorbable surgical suture. Most of the 49 reports describe the thread or needle breaking, separating, or fraying during surgery; two mention a needle or suture fragment left in the patient. There are no deaths and 2 injuries. One recall, opened in December 2024, involves sutures whose packaging seal may have been open, which could compromise sterility.

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
49
Deaths reported
0
Injuries reported
2
Recalls naming it
1

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10705031021037), received between Apr 16, 2019 and Aug 18, 2026 — classified as 2 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Break” (23 reports).

1 FDA recall record name this device's identifier, 1 still open.

20 other recalls cover devices cleared under the same FDA submission (K133356); 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 3 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 2 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 4 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 2 reportsApr 2026: 0 reportsMay 2026: 2 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Dec 20, 2024Open, Classified

    Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

    Z-1096-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Break23
  • Material Separation22
  • Material Frayed11
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions39
  • No Consequences Or Impact To Patient8
  • Foreign Body In Patient2
  • Dyspnea1
  • Hemorrhage/Blood Loss/Bleeding1
  • Low Blood Pressure/ Hypotension1
  • Unspecified Tissue Injury1

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 18, 2026Material Separation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50301079 ↗
  • MalfunctionMay 5, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. 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 25083918 ↗
  • MalfunctionMay 5, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. 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 25083916 ↗
  • MalfunctionMar 25, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE WIRES BROKE DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24685803 ↗
  • MalfunctionMar 24, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE WIRES BROKE DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24676228 ↗
  • MalfunctionDec 22, 2025Break; Break

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A BILATERAL INGUINAL HERNIA SURGERY (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY OF THE FIRST SIDE, THE RIGHT SIDE, WHEN SUTURING A PLANE, THE NEEDLE BROKE AT THE CRIMPING ZONE, PLANTING ITSELF ENTIRELY IN THE PATIENT. THE NEEDLE REMAINED IN THE PATIENT. THAT WAS CONFIRMED BY AN INTRA-OP INTENSIFYING SCREEN. THE PATIENT SHOULD BE SEEN IN CONSULTATION ON DECEMBER 17. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

    MAUDE report 23863425 ↗
  • MalfunctionOct 15, 2025Break; Material Separation; Break; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OVARIAN FIXATION ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, A GYNECOLOGIST SURGEON ENCOUNTERED A PROBLEM WITH A PROLENE 2-0 SUTURE ON AN OVARIAN FIXATION PROCEDURE. INDEED, THE NEEDLE PULLED OFF: "NEEDLE BREAKAGE DURING ITS USE IN LAPAROSCOPY - NO SIGNIFICANT TRACTION ACHIEVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23280222 ↗
  • MalfunctionJul 15, 2025Material Frayed; Material Frayed

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD IS 'FRAYING' DURING THE OPERATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22515844 ↗
  • MalfunctionJul 9, 2025Break; Material Separation; Break; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A INGUINAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WIRE LOOSENED IN THE ROOM ON AN INGUINAL HERNIA. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22461496 ↗
  • MalfunctionJun 23, 2025Material Frayed; Material Frayed

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD IS 'FRAYING' DURING THE OPERATION WHEN FIXING A HERNIA PLATE. HE USED SEVERAL THREADS WITH THE SAME DEFECT FROM 2 DIFFERENT BOXES WITH THE SAME LOT NUMBER. THE SURGEON USED A THREAD WITH A DIFFERENT LOT NUMBER WITHOUT ANY ISSUES." NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22306778 ↗
  • MalfunctionJun 23, 2025Material Frayed; Material Frayed

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD IS 'FRAYING' DURING THE OPERATION WHEN FIXING A HERNIA PLATE. HE USED SEVERAL THREADS WITH THE SAME DEFECT FROM 2 DIFFERENT BOXES WITH THE SAME LOT NUMBER. THE SURGEON USED A THREAD WITH A DIFFERENT LOT NUMBER WITHOUT ANY ISSUES."NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22306708 ↗
  • MalfunctionJun 23, 2025Material Frayed; Material Frayed

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD IS 'FRAYING' DURING THE OPERATION WHEN FIXING A HERNIA PLATE. HE USED SEVERAL THREADS WITH THE SAME DEFECT FROM 2 DIFFERENT BOXES WITH THE SAME LOT NUMBER. THE SURGEON USED A THREAD WITH A DIFFERENT LOT NUMBER WITHOUT ANY ISSUES."NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22306706 ↗
  • MalfunctionJun 23, 2025Material Frayed; Material Frayed

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD IS 'FRAYING' DURING THE OPERATION WHEN FIXING A HERNIA PLATE. HE USED SEVERAL THREADS WITH THE SAME DEFECT FROM 2 DIFFERENT BOXES WITH THE SAME LOT NUMBER. THE SURGEON USED A THREAD WITH A DIFFERENT LOT NUMBER WITHOUT ANY ISSUES."NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22306701 ↗
  • MalfunctionApr 25, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE THREAD BROKE ALONG ITS LENGTH DURING AN INGUINAL HERNIA. CLINICAL CONSEQUENCES OBSERVED AND MEASURES AND ACTIONS TAKEN: ALL THREADS OF THIS REFERENCE AND LOT HAVE BEEN SET ASIDE AND WILL NO LONGER BE USED BECAUSE THIS THREAD IS USED FOR DIFFICULT AND SENSITIVE PROCEDURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21908409 ↗
  • MalfunctionSep 24, 2024Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THE NEEDLE COMES LOOSE FROM THREAD. THE PRODUCT RECEIVED FOR ANALYSIS WAS IDENTIFIED AS PRODUCT CODE 8833H. VISUAL INSPECTION AND METALLURGICAL ANALYSIS WERE PERFORMED ON THE RETURNED PRODUCT. A FRACTURE WAS OBSERVED AT THE SUTURE ATTACHMENT OF THE NEEDLE. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. THE NEEDLE WAS NOTED WITH MARKS THAT APPEARS TO BE BY SURGICAL INSTRUMENT. A SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THE EVALUATION OF THE SAMPLE REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE FRACTURE MODE. MECHANICAL DAMAGE OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDE ADDITIONAL EVIDENCE THAT THE FAILURE WAS INDUCED BY MECHANICAL DEFORMATION LEADING TO DUCTILE OVERLOAD. THIS WAS A DUCTILE FRACTURE. THE EVIDENCE OF THIS EXAMINATION INDICATES THAT THE BREAKAGE OCCURRED AT THE ATTACHMENT ARE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20297211 ↗
  • MalfunctionAug 22, 2024Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LOW ANTERIOR RESECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT HE WAS ALERTED BY SCRUB TECH, THAT THE SURGEON HAD A SUTURE HAD BROKEN DURING A ROBOTIC LAR PROCEDURE. NO PATIENT CONSEQUENCE WAS REPORTED. ONE DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20042985 ↗
  • InjuryJun 17, 2024Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LONGO OPERATION ON (B)(6) 2024 AND SUTURE WAS USED FOR THE ANASTOMOSIS AT THE END OF THE PROCEDURE. DURING THE LAST STITCH AT A DEPTH OF APPROX. 7-8 CM IN THE RECTUM, THE TIP OF THE NEEDLE BROKE OFF AND GOT STUCK IN THE PATIENT. INTRAOPERATIVELY, THE TIP OF THE NEEDLE COULD BE LOCATED WITH THE X-RAY MACHINE BUT COULD NOT BE RETRIEVED. THE DAMAGE TO THE PATIENT WOULD HAVE BEEN TOO GREAT, AS THE OPERATING FIELD WOULD HAVE HAD TO BE CONSIDERABLY ENLARGED. THE DOCTORS THEREFORE DECIDED TO END THE OPERATION. THE PATIENT WAS INFORMED AFTERWARDS ABOUT THE EVENT AND THE FURTHER PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

    MAUDE report 19546159 ↗
  • InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN RIGHT LOWER LOBECTOMY FOR STAGE A OF PRIMARY LUNG CANCER ON AN UNKNOWN DATE AND SUTURE WAS USED FOR AN AIR LEAK FROM THE DEFECTIVE PART OF INTERLOBAR PLEURA WHERE WAS EXFOLIATED TO ADHESION WITH THE LOWER LUNG. THE POSTOPERATIVE COURSE WAS UNEVENTFUL. THE PATIENT WAS THEN NOT FREE OF AN ABNORMAL FINDING BY THE CHEST X-RAY EXAMINATION ON THE 6TH DAY AFTER SURGERY, THE DAY OF DISCHARGE. HOWEVER, 11 DAYS AFTER THE OPERATION, THE PATIENT EXPERIENCED DYSPNEA AND WAS TAKEN TO THE EMERGENCY ROOM, AND HIS SYSTOLIC BLOOD PRESSURE WAS 73 MMHG, AND HIS HEART RATE WAS 68 BEATS/MIN AT THAT TIME. AN EMERGENCY THORACOTOMY WAS PERFORMED BECAUSE IT A HEMOTHORAX WAS CONFIRMED BY THE CHEST X-RAY EXAMINATION AND THE DOCTOR DIAGNOSED POSTOPERATIVE BLEEDING. A BLOOD CLOT WAS FOUND IN THE PLEURAL CAVITY, AND WHEN THE BLOOD CLOT WAS REMOVED, IT WAS RECOGNIZED THAT AN ARTERIAL BLEEDING OCCURRED FROM THE PINHOLE OF THE PARIETAL PLEURA. THE PINHOLE WAS SUTURED AND TREATED WITH FIBRIN GLUE. AFTER THE BLEEDING STOPPED, IT WAS FOUND THAT A STUMP OF SUTURE USED IN THE FIRST OPERATION WAS PROTRUDING FROM THE LUNG, AND THE DOCTOR HAD CONSIDERED THAT

    Patient problems: Dyspnea; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

    MAUDE report 19476726 ↗
  • MalfunctionMay 23, 2024Break; Material Separation; Break; Material Separation

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC HERNIA REPAIR ON (B)(6) 2024 AND SUTURE WAS USED. THE SH NEEDLE BROKE OFF IN THE PATIENT DURING SURGERY. A FLUOROSCOPY WAS UTILIZED TO FIND AND REMOVE THE BROKEN NEEDLE FROM THE PATIENT. THIS DELAYED THE CASE BY 1 HOUR. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19383718 ↗
  • MalfunctionApr 10, 2024Break; Break

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE FOR EVENTRATION ON (B)(6) 2024 AND SUTURE WAS USED. AT THE BEGINNING OF A SUTURE WITH "PROLENE" THREAD, THE NEEDLE WAS BROKEN. A FRAGMENT OF THE NEEDLE REMAINING IN THE PATIENT'S TISSUE, A PART OF NEEDLE WITH THE THREAD ON THE NEEDLE SUPPORT. THE FRAGMENT HAD BEEN RECOVERED FROM THE PATIENT AND THE BROKEN WIRE HAD BEEN REMOVED. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19080915 ↗
  • MalfunctionDec 20, 2023Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A COLON RESECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER COMPLAINS OF A CHANGE IN THE STRENGTH OF PROLENE SUTURE, WHICH THEY HAVE BEEN USING FOR A LONG TIME TO FIX A CIRCULAR STAPLER CUP. NOW THE FILAMENT HAS CHANGED IN STRENGTH AND IS TEARING WITH SUTURING TECHNIQUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18368415 ↗
  • MalfunctionDec 13, 2023Break; Material Frayed; Break; Material Frayed

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND A SUTURE WAS USED. DURING THE PROCEDURE, TWO OF THE SUTURES SNAPPED AND FRAYED. UNKNOWN AS TO WHAT TYPE OF TISSUE WAS BEING SUTURED AT THE TIME OF BREAKAGE. ANOTHER LIKE SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO DEVICE WILL BE RETURNED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18318082 ↗
  • MalfunctionDec 13, 2023Break; Material Frayed; Break; Material Frayed

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 15-NOV-2023 AND A SUTURE WAS USED. DURING THE PROCEDURE, TWO OF THE SUTURES SNAPPED AND FRAYED. UNKNOWN AS TO WHAT TYPE OF TISSUE WAS BEING SUTURED AT THE TIME OF BREAKAGE. ANOTHER LIKE SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO DEVICE WILL BE RETURNED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18318081 ↗
  • MalfunctionFeb 16, 2023Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A INGUINAL HERNIA REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE PULL-OFF DURING TISSUE PASSAGE (MUSCLE). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16385520 ↗
  • MalfunctionFeb 16, 2023Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A INGUINAL HERNIA REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE PULL-OFF DURING TISSUE PASSAGE (MUSCLE). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16385519 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133356. One submission often covers many models, so check the product and lot details in each record.

  • Z-1515-2025 · Mar 7, 2025 · Open, Classified
    PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
  • Z-2460-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
  • Z-2456-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
  • Z-2466-2018 · May 7, 2018 · Terminated
    PRONOVA SUTURE BLUE 122CM M1.5, D10189
  • Z-2452-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
  • Z-2448-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
  • Z-2464-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
  • Z-2465-2018 · May 7, 2018 · Terminated
    PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
  • Z-2459-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
  • Z-2449-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
  • Z-2458-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
  • Z-2450-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
  • Z-2463-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
  • Z-2454-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
  • Z-2457-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688

…and 5 more.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.