STRATAFIX SXPP2B201Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705031464506), received between Jan 12, 2024 and Mar 10, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (18 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Positioning Failure; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2026 AND BARBED SUTURE WAS USED. THE BARB DIDN'T LOCK AND SUTURE DETACHED FROM NEEDLE. NO REPORTED ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560022 ↗
• MalfunctionMar 10, 2026Positioning Failure; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2026 AND BARBED SUTURE WAS USED. THE BARB DIDN'T LOCK AND SUTURE DETACHED FROM NEEDLE. NO REPORTED ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560018 ↗
• MalfunctionMar 10, 2026Positioning Failure; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2026 AND BARBED SUTURE WAS USED. THE BARB DIDN'T LOCK AND SUTURE DETACHED FROM NEEDLE. NO REPORTED ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560016 ↗
• MalfunctionFeb 19, 2026Positioning Failure; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2026 AND BARBED SUTURE WAS USED. THE BARB DIDN'T LOCK AND SUTURE DETACHED FROM NEEDLE. NO REPORTED ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390942 ↗
• MalfunctionAug 6, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE DIDN¿T LOCK AND IT LOOSENED WHEN SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729263 ↗
• MalfunctionAug 6, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE DIDN'T LOCK AND IT LOOSENED WHEN SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729262 ↗
• MalfunctionAug 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE DIDN¿T LOCK AND IT LOOSENED WHEN SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720619 ↗
• MalfunctionAug 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE DIDN'T LOCK AND IT LOOSENED WHEN SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720609 ↗
• MalfunctionAug 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE DIDN¿T LOCK AND IT LOOSENED WHEN SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720599 ↗
• MalfunctionAug 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE DIDN¿T LOCK AND IT LOOSENED WHEN SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720581 ↗
• MalfunctionAug 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE DIDN¿T LOCK AND IT LOOSENED WHEN SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720560 ↗
• MalfunctionAug 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE DIDN'T LOCK AND IT LOOSENED WHEN SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720554 ↗
• MalfunctionAug 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE DIDN¿T LOCK AND IT LOOSENED WHEN SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720541 ↗
• MalfunctionAug 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE DIDN'T LOCK AND IT LOOSENED WHEN SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720539 ↗
• MalfunctionAug 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE DIDN¿T LOCK AND IT LOOSENED WHEN SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720410 ↗
• MalfunctionAug 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE DIDN¿T LOCK AND IT LOOSENED WHEN SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720321 ↗
• MalfunctionJul 17, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE SURGERY PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE STRATAFIX SUTURE DIDN¿T ADEQUATELY SECURE THE WOUND. UPON TESTING KNEE FLEXION AFTER CLOSURE THE SUTURE LOOSENED AND COME OUT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534921 ↗
• MalfunctionJul 17, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE SURGERY PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE STRATAFIX SUTURE DIDN¿T ADEQUATELY SECURE THE WOUND. UPON TESTING KNEE FLEXION AFTER CLOSURE, THE SUTURE LOOSENED AND COME OUT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534888 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE MULTIPLE TIMES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559903 ↗
• MalfunctionJan 12, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE SUTURE IS A SMOOTH SUTURE, BUT IT IS SUPPOSED TO BE A BARB SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501968 ↗