STRATAFIX SXPP2B202Recalls & reported problems
Ethicon, LLC · Stratafix (Spiral PDS Plus), Bidirectional · Class 2 · Implant
Quick summary
This Ethicon Stratafix spiral PDS Plus bidirectional barbed suture is a absorbable surgical suture. The 27 reports mostly describe the suture not staying put during surgery — loosening from its placement and in one case traveling through a patient's leg until it exited the skin — plus needles detaching while suturing and the suture failing to lock. No deaths and no injuries were reported, and no recalls name this device. Reports rose from 3 in the earlier 12 months to 11 in the most recent 12 months.
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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705031464551), received between Nov 3, 2023 and Apr 17, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (15 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
- Positioning Failure15
- Material Separation8
- Break3
- Delivered as Unsterile Product1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Pocket Erosion1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED TO REP BY A ORTHOPEDIC APP THAT A BARBED SUTURE RELEASED ITSELF FROM THE ORIGINAL PLACEMENT POSITION AND TRAVELED THROUGH THE PATIENTS LEG UNTIL THE PATIENTS BODY SPIT IT OUT SEVERAL INCHES FROM THE ORIGINAL POINT OF PLACEMENT. DEVICE AVAILABILITY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Pocket Erosion
MAUDE report 24912489 ↗MalfunctionApr 6, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT TO THE SALES REP THAT DURING THE TOTAL HIP/KNEE PROCEDURE, THE NEEDLES WERE FALLING OFF WHILST SUTURING. THE NEEDLES WERE RETRIEVED AND THE NEEDLES WEREN'T ON THE PATIENT'S BODY. DEVICES WILL BE RETURNED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791624 ↗MalfunctionApr 6, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT TO THE SALES REP THAT DURING THE TOTAL HIP/KNEE PROCEDURE, THE NEEDLES WERE FALLING OFF WHILST SUTURING. THE NEEDLES WERE RETRIEVED AND THE NEEDLES WEREN'T ON THE PATIENT'S BODY. DEVICES WILL BE RETURNED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791620 ↗MalfunctionMar 23, 2026Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES DID NOT LOCK DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24669027 ↗MalfunctionMar 23, 2026Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES DID NOT LOCK DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24668207 ↗MalfunctionMar 23, 2026Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES DID NOT LOCK DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24668205 ↗MalfunctionMar 23, 2026Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES DID NOT LOCK DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24668204 ↗MalfunctionMar 23, 2026Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES DID NOT LOCK DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24668191 ↗MalfunctionMar 23, 2026Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES DID NOT LOCK DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24668188 ↗MalfunctionJan 9, 2026Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING SURGERY, THE DOCTOR USED STRATAFIX SXPP2B202 TO SUTURE THE FASCIA, BUT THE SUTURE DID NOT FIX PROPERLY. AFTER MULTIPLE PASSES AND ALMOST COMPLETING THE CLOSURE, THE SUTURE STILL FAILED TO SECURE THE TISSUE. EVENTUALLY, STRATAFIX HAD TO BE CUT AND REPLACED WITH VICRYL FOR RE-SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24026890 ↗MalfunctionDec 18, 2025Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT THAT THE SUTURE FEELS SMOOTHER THAN THEY REMEMBER AND NOT "CATCHING" THE TISSUE AS THEY WOULD LIKE. THERE WAS NO INJURIES OR ADVERSE EVENT TO THE PATIENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23837266 ↗MalfunctionJan 27, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING TWO TOTAL KNEE REPLACEMENT PROCEDURES THAT THE NEEDLE TIP BROKE OFF THE NEEDLE WHILE SUTURING THE KNEE CAPSULE AND SUBCUTICULAR TISSUE. UNKNOWN IF X-RAY WAS NEEDED. TIP OF THE NEEDLE WAS RECOVERED. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21240876 ↗MalfunctionJan 27, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING TWO TOTAL KNEE REPLACEMENT PROCEDURES THAT THE NEEDLE TIP BROKE OFF THE NEEDLE WHILE SUTURING THE KNEE CAPSULE AND SUBCUTICULAR TISSUE. UNKNOWN IF X-RAY WAS NEEDED. TIP OF THE NEEDLE WAS RECOVERED. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21240870 ↗MalfunctionNov 5, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE OFF OF THE SUTURE WHEN THEY WERE USING IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20612297 ↗MalfunctionSep 20, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHILE OPENING STERILE SUPPLIES, A FOIL SUTURE PACKET WAS FOUND TO HAVE A HOLE IN IT AFTER IT HAD BEEN OPENED TO THE SURGICAL FIELD. THE HOLE WAS ONLY ABLE TO BE IDENTIFIED AFTER THE WRAP WAS OPENED AND HELD UP TO LIGHT TO BE INSPECTED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20268525 ↗MalfunctionJun 12, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE POPPED OFF OF THE SUTURE WITH VERY LITTLE PULLING OR FORCE WHILE SUTURING. NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19525462 ↗MalfunctionJun 12, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE POPPED OFF OF THE SUTURE WITH VERY LITTLE PULLING OR FORCE WHILE SUTURING. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19525461 ↗MalfunctionJun 4, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT PATIENTS UNDERWENT TOTAL KNEE REPLACEMENTS ON UNKNOWN DATES IN 2024, AND BARBED SUTURE WAS USED. DURING THE PROCEDURES THE STRATAFIX FELT LIKE A NORMAL PDS. THE BARBS WERE NOT CATCHING. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19461741 ↗MalfunctionJun 4, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT PATIENTS UNDERWENT TOTAL KNEE REPLACEMENTS ON UNKNOWN DATES IN 2024, AND BARBED SUTURE WAS USED. DURING THE PROCEDURES THE STRATAFIX FELT LIKE A NORMAL PDS. THE BARBS WERE NOT CATCHING. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19461735 ↗MalfunctionJun 4, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT PATIENTS UNDERWENT TOTAL KNEE REPLACEMENTS ON UNKNOWN DATES IN 2024, AND BARBED SUTURE WAS USED. DURING THE PROCEDURES THE STRATAFIX FELT LIKE A NORMAL PDS. THE BARBS WERE NOT CATCHING. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19461719 ↗MalfunctionJun 4, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT PATIENTS UNDERWENT TOTAL KNEE REPLACEMENTS ON UNKNOWN DATES IN 2024, AND BARBED SUTURE WAS USED. DURING THE PROCEDURES THE STRATAFIX FELT LIKE A NORMAL PDS. THE BARBS WERE NOT CATCHING. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19461706 ↗MalfunctionMay 13, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT PATIENTS UNDERWENT TOTAL KNEE REPLACEMENTS ON UNKNOWN DATES IN 2024, AND BARBED SUTURE WAS USED. DURING THE PROCEDURES THE STRATAFIX FELT LIKE A NORMAL PDS. THE BARBS WERE NOT CATCHING. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19304692 ↗MalfunctionMay 13, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT PATIENTS UNDERWENT TOTAL KNEE REPLACEMENTS ON UNKNOWN DATES IN 2024, AND BARBED SUTURE WAS USED. DURING THE PROCEDURES THE STRATAFIX FELT LIKE A NORMAL PDS. THE BARBS WERE NOT CATCHING. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19304667 ↗MalfunctionMar 6, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE POPPED OFF DURING THE PROCEDURE. NO PATIENT HARM REPORTED DURING THE CASE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18848023 ↗MalfunctionMar 6, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE POPPED OFF DURING THE PROCEDURE. NO PATIENT HARM REPORTED DURING THE CASE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18848017 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.