STRATAFIX SXPP2B409Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031464674), received between May 8, 2025 and Jun 22, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT REQUIRED A REVISION. THE PATIENT EXPERIENCED A SUPERFICIAL DEHISCENCE OF ABOUT 0.5-1 CM. THE DOCTOR HAD TO REMOVE SUTURE AND THEN USE A TOPICAL SKIN ADHESIVE AND THE PATIENT HEALED FINE AFTER THAT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 25579288 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT REQUIRED A REVISION. THE PATIENT EXPERIENCED A SUPERFICIAL DEHISCENCE OF ABOUT 0.5-1 CM. THE DOCTOR HAD TO REMOVE SUTURE AND THEN USE A TOPICAL SKIN ADHESIVE AND THE PATIENT HEALED FINE AFTER THAT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 25579287 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT REQUIRED A REVISION. THE PATIENT EXPERIENCED A SUPERFICIAL DEHISCENCE OF ABOUT 0.5-1 CM. THE DOCTOR HAD TO REMOVE SUTURE AND THEN USE A TOPICAL SKIN ADHESIVE AND THE PATIENT HEALED FINE AFTER THAT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 25579279 ↗
• MalfunctionJun 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT AFTER TAKING THE FINAL BACK PASS WITH THE SUTURE ONE OF THE NEEDLES POPPED OFF. NO PATIENT CONSEQUENCE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363024 ↗
• MalfunctionNov 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING AN ORTHOPEDIC PROCEDURE, A NEEDLE POPPED OFF TWICE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485965 ↗
• MalfunctionNov 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING AN ORTHOPEDIC PROCEDURE, A NEEDLE POPPED OFF TWICE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485960 ↗
• MalfunctionSep 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE NURSE TO THE SALES REP THAT THE NEEDLE POPPED OFF THE SUTURE. NO FURTHER INFORMATION PROVIDED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23181485 ↗
• MalfunctionJun 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT PRIOR TO AN UNKNOWN PROCEDURE, THERE'S ANOTHER SUTURE WHERE ONE OF THE NEEDLES WAS OFF THE STITCH WHEN THEY OPENED THE PACKAGE. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. ONE DEVICE WILL BE RETURNED. UPON VISUAL INSPECTION OF THE DETACHED NEEDLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE BARREL HOLE WAS EXAMINED UNDER MAGNIFICATION, AND NO SUTURE REMNANT WAS NOTED. IN ADDITION, THE NEEDLE SUTURE COMBINATION WAS VISUALLY INSPECTED, AND THE SWAGE AREA WAS NOTED TO BE AS EXPECTED. THE SUTURE WAS EXAMINED AND A SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS DETACHED FROM THE NEEDLE SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338917 ↗
• MalfunctionJun 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE THAT WHEN THE SUTURE PACKAGE WAS OPENED THE NEEDLE WAS NOT ATTACHED TO THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. SUTURE, NEEDLE AND PACKAGING RETURNING. UPON RETURN AND EVALUATION OF THE DETACHED NEEDLE AND SUTURE PIECE, A SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE AND SUTURE WAS DETACHED FROM THE NEEDLE SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIRED STANDARDS. I N THE INSPECTION OF THE NEEDLE-SUTURE PIECE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED, AND NO NEEDLE PULL OFF WAS NOTED. AS THE SUTURE IS ABSORBABLE AND THE DURATION OF EXPOSURE OF THE SUTURE IN THE ENVIRONMENT COULD NOT BE DETERMINED, THE FUNCTIONAL TEST COULD NOT BE PERFORMED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195149 ↗
• MalfunctionJun 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE POPPED OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152299 ↗
• MalfunctionMay 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT A NEEDLE POPPED OF THE SUTURE. THEY OPENED ANOTHER OF THE SAME SUTURE TO FINISH THE CLOSURE. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089078 ↗
• MalfunctionMay 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT A NEEDLE POPPED OF THE SUTURE. THEY OPENED ANOTHER OF THE SAME SUTURE TO FINISH THE CLOSURE. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089061 ↗
• MalfunctionMay 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT A NEEDLE POPPED OF BARBED SUTURE. THEY OPENED ANOTHER OF THE SAME SUTURE TO FINISH THE CLOSURE. SALES REP HAVE THE NEEDLE AND ALSO THE PACKAGE TO RETURN. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054066 ↗
• MalfunctionMay 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON WAS CLOSING THE SUBCUTANEOUS LAYER OF TISSUE AND ONE NEEDLE POPPED OFF EASILY AS HE WAS SUTURING. HE HAD ALREADY DONE HIS BACK PASSES SO NO ADDITIONAL INTERVENTION WAS NEEDED. PRODUCT RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002967 ↗
• MalfunctionMay 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON WAS CLOSING THE SUBCUTANEOUS LAYER OF TISSUE AND ONE NEEDLE POPPED OFF EASILY AS HE WAS SUTURING. HE HAD ALREADY DONE HIS BACK PASSES SO NO ADDITIONAL INTERVENTION WAS NEEDED. PRODUCT RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002810 ↗
• MalfunctionMay 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY THE EMPLOYEE THAT THE SURGEON WAS CLOSING THE SUBCUTANEOUS LAYER OF TISSUE AND ONE NEEDLE POPPED OFF EASILY AS HE WAS SUTURING. NO ADDITIONAL INTERVENTION WAS NEEDED. PRODUCT RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002537 ↗
• MalfunctionMay 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WAS CLOSING THE SUBCUTANEOUS LAYER OF TISSUE AND ONE NEEDLE POPPED OFF EASILY AS HE WAS SUTURING. HE HAD ALREADY DONE HIS BACK PASSES SO NO ADDITIONAL INTERVENTION WAS NEEDED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994069 ↗
• MalfunctionMay 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE SURGEON TOOK THE FIRST PASS IN TISSUE WITH 1 OF THE NEEDLES, HE NOTICED THE SECOND NEEDLE THAT WAS ATTACHED ON A DRIVER HAD POPPED OFF. ANOTHER DEVICE OF THE SAME SUTURE WAS OPENED TO FINISH THE CLOSURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989667 ↗