STRATAFIX SXPP1B402Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031236059), received between Dec 21, 2020 and Jun 9, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Aug 28, 2019Terminated

   The product do not meet certain internal testing specifications.

   Z-1335-2020 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE SURGEON COMPLAINED THAT THE BARBS WERE NOT CATCHING AS HE PASSED THROUGH THE HIP FACIA TISSUE. HE WAS CONCERNED OF A DEHISCENCE SO HE REMOVED THE SUTURE AND TRIED ANOTHER, BUT HAD THE SAME RESULT. THE SURGEON RAN THE STITCH AND TIED IT AT THE END AND ALSO PUT IN INTERRUPTED VICRYL STITCH TO BE SAFE. THE SURGERY WAS DELAYED FOR FIVE MINUTES, BUT COMPLETED SUCCESSFULLY USING A SECOND SUTURE AND TIED INTERRUPTED VICRYL. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097750 ↗
• MalfunctionJun 9, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE SURGEON COMPLAINED THAT THE BARBS WERE NOT CATCHING AS HE PASSED THROUGH THE HIP FACIA TISSUE. HE WAS CONCERNED OF A DEHISCENCE SO HE REMOVED THE SUTURE AND TRIED ANOTHER, BUT HAD THE SAME RESULT. THE SURGEON RAN THE STITCH AND TIED IT AT THE END AND ALSO PUT IN INTERRUPTED VICRYL STITCH TO BE SAFE. THE SURGERY WAS DELAYED FOR FIVE MINUTES, BUT COMPLETED SUCCESSFULLY USING A SECOND SUTURE AND TIED INTERRUPTED VICRYL. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097746 ↗
• InjuryOct 28, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6)2022 AND A BARBED SUTURE WAS USED FOR FASCIA CLOSURE. POST-OP, ON (B)(6) 2022, AN X-RAY WAS DONE AND DUE TO BLEEDING (THAT ANOTHER SURGEON THOUGHT WAS UNDER THE SKIN), THE SURGEON REDID THE OUTER LAYER. THE PATIENT GOT SENT HOME BUT LATER IN THE DAY, IT STARTED TO HURT AND THE BLEEDING DIDN´T STOP. THE PATIENT CAME BACK TO THE CLINIC AND THE ORTHOPEDIC SURGEON THAT DID THE SURGERY SAW THAT THE BARBED HAD RUPTURED IN 4 PLACES CAUSING A TOTAL FASCIA RUPTURE. THE ORTHO SURGEON HAD TO REOPEN THE WOUND AND RE-SUTURE. IT WAS OPINED THAT THE TOTAL RUPTURE OF FASCIA CLOSURE WAS DUE TO USE OF THE WRONG TYPE OF BARBED SUTURE. IT WAS STATED THAT THE RISK OF AN SSI IS HIGH BUT TOO EARLY TO SAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 15692836 ↗
• MalfunctionDec 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11052280 ↗