STRATAFIX SXPP1A203Recalls & reported problems
Ethicon, LLC · Violet Antibacterial Polydioxanone, Knotless Tissue Control Device · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Stratafix knotless barbed suture is a surgical stitch that dissolves over time. Most of the 58 reports describe the thread breaking or coming apart during surgery, sometimes detaching from the needle at the first pass and delaying the operation, with a few reports of wound reopening. Three injuries were reported and no deaths. No recalls name this device, and reports in the past 12 months (8) are down from 18 in the year before.
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
- 62
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10705031245198), received between Mar 12, 2021 and Sep 30, 2026 — classified as 3 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Break” (42 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break42
- Material Separation17
- Adverse Event Without Identified Device or Use Problem3
- Material Frayed1
- Material Twisted/Bent1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- Wound Dehiscence3
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950068 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950062 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950051 ↗MalfunctionSep 18, 2026Break
It was reported a patient underwent Total Knee Replacement procedure on (b)(6)2026 and barbed suture was used. Surgeon was using suture to close the capsule. During the closure the suture broke into two parts twice. The incident delayed the operating time as they removed the broken suture and used the convention one. Additional information has been requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816417 ↗MalfunctionSep 18, 2026Break
It was reported a patient underwent Total Knee Replacement procedure on (b)(6)2026 and barbed suture was used. Surgeon was using suture to close the capsule. During the closure the suture broke into two parts twice. The incident delayed the operating time as they removed the broken suture and used the convention one. Additional information has been requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816413 ↗MalfunctionJun 18, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY AT THE FIRST BITE (FIRST PASS) THREAD IS DETACHED FROM THE SWAGE POINT, SAME THING HAPPEN FOR 3 BARBED SUTURES AT A TIME IN ONE SURGERY. THE SURGERY WAS DELAYED 15 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25552354 ↗MalfunctionJun 18, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY AT THE FIRST BITE (FIRST PASS) THREAD IS DETACHED FROM THE SWAGE POINT, SAME THING HAPPEN FOR 3 BARBED SUTURES AT A TIME IN ONE SURGERY. THE SURGERY WAS DELAYED 15 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25552344 ↗MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE, THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056956 ↗MalfunctionApr 21, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24940330 ↗MalfunctionJan 23, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. NEEDLE CAME OFF IN FIRST BITE DURING CAPSULE CLOSURE ON TKR. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24161879 ↗MalfunctionDec 29, 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 BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905873 ↗MalfunctionDec 29, 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 BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905872 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE BARBED SUTURE BROKEN DURING SUTURING IN SPINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438512 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE BARBED SUTURE BROKEN DURING SUTURING IN SPINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438511 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE BARBED SUTURE BROKEN DURING SUTURING IN SPINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438510 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE BARBED SUTURE BROKEN DURING SUTURING IN SPINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438509 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE BARBED SUTURE BROKEN DURING SUTURING IN SPINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438508 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE BARBED SUTURE BROKEN DURING SUTURING IN SPINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438507 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE BARBED SUTURE BROKEN DURING SUTURING IN SPINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438504 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE BARBED SUTURE BROKEN DURING SUTURING IN SPINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438503 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE BARBED SUTURE BROKEN DURING SUTURING IN SPINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438501 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE BARBED SUTURE BROKEN DURING SUTURING IN SPINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438500 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE BARBED SUTURE BROKEN DURING SUTURING IN SPINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438491 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE BARBED SUTURE BROKEN DURING SUTURING IN SPINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438473 ↗MalfunctionOct 21, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, STRATAFIX SYMMETRIC PDS PLUS SUTURE HAS BEEN DETACHED FROM NEEDLE AFTER THE INITIAL BITE. SAME HAS HAPPENED FOR ANOTHER SUTURE ALSO. TWO FOILS HAS BEEN COMPLAINT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348907 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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