STRATAFIX SXPP1B458Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031240858), received between Jun 2, 2025 and Jul 16, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHILE CLOSING THE OPERATION SITE (RIGHT MEDIAL PARTIAL KNEE REPLACEMENT) USING A BARBED SUTURE 2-0. ON THE FINAL STITCH THE NEEDLE BROKE INTO TWO PARTS LEAVING ONE HALF IN THE NEEDLE HOLDER AND THE OTHER IN THE PATIENT. NOTHING WAS DONE DIFFERENTLY WHEN CLOSING THEN ANY OTHER SURGERY, IT WOULD SEEM THE EQUIPMENT WAS AT FAULT. ONCE LOCATING THE SUTURE END FROM THE PATIENT WE WERE HAPPY THAT ALL PARTS WERE PRESENT AND CORRECT FOR OUT FINAL COUNT LEAVING NOTHING IN THE PATIENT. THE PHYSICIAN STATED, ¿IN MY ASSESSMENT I FEEL THE EQUIPMENT WAS AT FAULT, THE SKIN DID NOT SEEM TOUGH AND THE SUTURE HAD BEEN WORKING FINE UNTIL THE FINAL STITCH.¿ NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523328 ↗
• MalfunctionJun 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT THE NEEDLE POPPED OFF THE SUTURE WHILE SUTURING THE VAGINAL CUFF. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. . NO DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128041 ↗