PROLENE HS6855HRecalls & reported problems
Ethicon, LLC · PROLENE (Polypropylene) Suture Blue Monofilament, Hemo-Seal Needle Suture, Sterile, nonabsorbable surgical suture · Class 2 · Implant
Quick summary
This Ethicon Prolene blue polypropylene surgical suture with a Hemo-Seal needle is a nonabsorbable stitching thread used to close tissue during surgery. Its 60 reports mostly describe the thread snapping while the surgeon ties a knot, or the needle pulling loose from the thread and dropping into the body, where it was quickly retrieved. One injury was reported and no deaths. There are no recalls naming 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
- 61
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10705031232761), received between Jun 10, 2020 and Aug 24, 2026 — classified as 1 injury, 60 malfunctions.
The most frequently reported specific device problem is “Break” (32 reports).
21 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
Most reported problems
Device problems
- Break32
- Material Separation28
- Material Frayed2
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- No Consequences Or Impact To Patient2
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50412718 ↗MalfunctionApr 15, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WITHOUT REASON, AND THE NEEDLE FELL INTO THE PATIENT'S BODY AND WAS QUICKLY FOUND, AND THE NEEDLE AND SUTURE WERE TAKEN OUT. NEW SUTURE WAS REPLACED TO COMPLETE THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24889128 ↗MalfunctionDec 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A TOTAL OF THREE SUTURES BROKE WHEN SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934698 ↗MalfunctionDec 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A TOTAL OF THREE SUTURES BROKE WHEN SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934687 ↗MalfunctionDec 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A TOTAL OF THREE SUTURES BROKE WHEN SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934646 ↗MalfunctionDec 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A TOTAL OF THREE SUTURES BROKE WHEN SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934597 ↗MalfunctionDec 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A TOTAL OF THREE SUTURES BROKE WHEN SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934588 ↗MalfunctionDec 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A TOTAL OF THREE SUTURES BROKE WHEN SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934577 ↗MalfunctionDec 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A TOTAL OF THREE SUTURES BROKE WHEN SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934569 ↗MalfunctionDec 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934543 ↗MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACIAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE GOT SPLIT IN THE SURGERY OF FACIAL SUTURE. 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 23923606 ↗MalfunctionDec 11, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT WHILE SEWING IN AORTIC GRAFT, NEEDLE POPPED OFF OF SUTURE. IT WAS AT BEGINNING OF SUTURING PROCESS. THE SUTURE MATERIAL WAS NOT CAUGHT ON ANYTHING TO CAUSE THE NEEDLE TO PULL OFF. NO DELAY WAS REPORTED. NO PATIENT HARM WAS THERE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23780481 ↗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, UPON OPENING THE STERILE PACKAGING, IT WAS DISCOVERED THAT THE SUTURE AT THE END OF THE NEEDLE AND THE JUNCTION OF THE SUTURE HAD BECOME FUZZY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, 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 23490688 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, ONE OF THE SUTURES HAD THE PROBLEM OF PULLING OFF SUTURE NEEDLE, THE OTHER ONE IS THE ISSUE OF SUTURE BREAKAGE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22319924 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, ONE OF THE SUTURES HAD THE PROBLEM OF PULLING OFF SUTURE NEEDLE, THE OTHER ONE IS THE ISSUE OF SUTURE BREAKAGE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22319922 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, ONE OF THE SUTURES HAD THE PROBLEM OF PULLING OFF SUTURE NEEDLE, THE OTHER ONE IS THE ISSUE OF SUTURE BREAKAGE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22319918 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, ONE OF THE SUTURE HAD THE PROBLEM OF PULLING OFF SUTURE NEEDLE, THE OTHER ONE IS THE ISSUE OF SUTURE BREAKAGE . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22319914 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, ONE OF THE SUTURE HAD THE PROBLEM OF PULLING OFF SUTURE NEEDLE, THE OTHER ONE IS THE ISSUE OF SUTURE BREAKAGE . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22319913 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, ONE OF THE SUTURE HAD THE PROBLEM OF PULLING OFF SUTURE NEEDLE, THE OTHER ONE IS THE ISSUE OF SUTURE BREAKAGE . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22319912 ↗MalfunctionJun 24, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, ONE OF THE SUTURES HAD THE PROBLEM OF PULLING OFF SUTURE NEEDLE, THE OTHER ONE IS THE ISSUE OF SUTURE BREAKAGE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22319909 ↗MalfunctionApr 22, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTO BI-FEMORAL BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING USE ON THE PATIENT, THE THREAD BROKE OFF FROM THE REST OF THE SUTURE. NEEDLE WAS FOUND; PATIENT IS FINE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21885883 ↗MalfunctionDec 10, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE GOT SPLIT IN THE SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20895790 ↗MalfunctionDec 10, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE GOT SPLIT IN THE SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20895726 ↗MalfunctionMar 26, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 14-MARCH-2024, AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18978034 ↗MalfunctionMar 26, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18978032 ↗
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, ClassifiedPROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
- Z-1096-2025 · Dec 20, 2024 · Open, ClassifiedPROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ca
- Z-2460-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
- Z-2459-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
- Z-2463-2018 · May 7, 2018 · TerminatedPROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
- Z-2453-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
- Z-2461-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
- Z-2458-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
- Z-2466-2018 · May 7, 2018 · TerminatedPRONOVA SUTURE BLUE 122CM M1.5, D10189
- Z-2464-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
- Z-2448-2018 · May 7, 2018 · TerminatedPROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
- Z-2449-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
- Z-2450-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
- Z-2456-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
- Z-2451-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
…and 6 more.
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
- PROLENE 8706HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 recalls294 reports
- PROLENE 8702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths254 reports
- PROLENE 8556HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death240 reports
- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
- PROLENE 8521HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths183 reports
- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.