STRATAFIX SXPP1A205Recalls & reported problems
Ethicon, LLC · Violet Antibacterial Polydioxanone, Knotless Tissue Control Device · Class 2 · Implant
All models of STRATAFIX (181)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon STRATAFIX knotless surgical suture is a barbed, absorbable stitch used to close tissue. Most of its 60 reports describe the suture breaking or separating, sometimes while a surgeon was pulling it tight during an operation; some mention wounds reopening, infection, or skin irritation, and 27 reports involved injuries. No deaths were reported. 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
- 65
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10705031245266), received between Jun 25, 2019 and Sep 29, 2026 — classified as 27 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Break” (52 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break52
- Material Separation8
- Adverse Event Without Identified Device or Use Problem7
- Material Integrity Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- Wound Dehiscence19
- Not Applicable15
- Unspecified Infection15
- Skin Inflammation/ Irritation6
- Pocket Erosion3
- Unspecified Tissue Injury3
- Erythema2
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936319 ↗MalfunctionSep 28, 2026Break; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918226 ↗MalfunctionSep 28, 2026Break; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918208 ↗MalfunctionSep 28, 2026Break; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918184 ↗MalfunctionSep 28, 2026Break; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918182 ↗MalfunctionDec 15, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING THE PROCEDURE, IT HAS COME TO MY NOTICE THAT THE STRATAFIX MATERIAL WAS CUT BACK-TO-BACK. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23805469 ↗MalfunctionDec 15, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING THE PROCEDURE, IT HAS COME TO MY NOTICE THAT THE STRATAFIX MATERIAL WAS CUT BACK-TO-BACK. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23805445 ↗InjuryNov 25, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. ON POST-OP DAY 1, THE PATIENT HEARD A SOUND FROM THEIR KNEE'S AREA. THE SURGEON FOUND THAT THE SUTURE BROKE. THEREFORE, THE PATIENT UNDERWENT A REVISION SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23645498 ↗MalfunctionNov 19, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BROKE INTRAOPERATIVELY WHILE PULLING TO ATTAIN THE REQUIRED TENSION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594057 ↗MalfunctionNov 3, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, FAULTY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23455555 ↗MalfunctionNov 3, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, FAULTY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23455248 ↗MalfunctionNov 3, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, FAULTY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23454437 ↗MalfunctionNov 3, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, FAULTY STRATAFIX WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452518 ↗MalfunctionNov 3, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, FAULTY STRATAFIX WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452345 ↗MalfunctionNov 3, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, FAULTY STRATAFIX WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452225 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE BARBED SUTURE WAS FAULTY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424866 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE BARBES SUTURE WAS FAULTY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424733 ↗InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A JOINT REPLACEMENT SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, 4 MONTHS LATER, THE PATIENT PRESENTED WITH WOUND ISSUES SUCH AS THE SUTURE BEING PUSHED OUT BY THE BODY. THE PATIENT RETURNED FOR REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Erythema; Pocket Erosion; Skin Inflammation/ Irritation
MAUDE report 23415852 ↗MalfunctionOct 15, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE AND BARBED SUTURE WAS USED. ON (B)(6) 2025 POST-OP, STRATAFIX -SXPP1A205 GETS ABSORBED IN ONE WEEK AS PER SURGEON CLAIM, IT WAS TKR SURGERY AND PATIENT CAME AGAIN FOR DISCOMFORT AFTER 7 DAYS, WHEN THEY OPEN THE WOUND STRATAFIX WAS ALMOST ABSORBED AND ONLY THIN STRAND COULD BE SEEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23302574 ↗MalfunctionOct 15, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BREAK DURING USE IN OPERATION CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301167 ↗MalfunctionSep 17, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BREAKAGE IN THE MIDDLE OF SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23075951 ↗InjurySep 5, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA (TOTAL KNEE ARTHROPLASTY) (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT CAME BACK TO THE SURGEON. THE SURGEON OBSERVED THAT THE BARBED SUTURES USED ON CAPSULE CLOSURE WERE BROKEN AFTER 12-15 DAYS DURING THE PHYSIOTHERAPY DURATION. THE PATIENT WAS RE-ADMITTED FOR RE-DO PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 22984208 ↗InjurySep 5, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA (TOTAL KNEE ARTHROPLASTY) (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT CAME BACK TO THE SURGEON. THE SURGEON OBSERVED THAT THE BARBED SUTURES USED ON CAPSULE CLOSURE WERE BROKEN AFTER 12-15 DAYS DURING THE PHYSIOTHERAPY DURATION. THE PATIENT WAS RE-ADMITTED FOR RE-DO PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 22984204 ↗MalfunctionAug 4, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, DR. WAS DOING BILATERAL TKR PROCEDURE BUT WHEN HE WAS USING STRATAFIX SYMMETRIC (SXPP1A205) TO CLOSE CAPSULE LAYER SO SUTURE GOT SEPARATED FROM SWAGE POINT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22698615 ↗MalfunctionAug 4, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, DR. WAS DOING BILATERAL TKR PROCEDURE BUT WHEN HE WAS USING STRATAFIX SYMMETRIC (SXPP1A205) TO CLOSE CAPSULE LAYER SO SUTURE GOT SEPARATED FROM SWAGE POINT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22698611 ↗
Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices
- STRATAFIX SXPP1A405Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE617 reports
- STRATAFIX SXPP1A400Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE485 reports
- STRATAFIX SXPP1A401Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE446 reports
- STRATAFIX SXPP1A301Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE443 reports
- STRATAFIX SXPP2B405Ethicon, LLC · Suture, surgical, absorbable, polydioxanone406 reports
- STRATAFIX SXPP1A406Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE339 reports
- STRATAFIX SXPP1A404Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death319 reports
- STRATAFIX SXPP1B420Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death229 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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