STRATAFIX SXPP2B420Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031464803), received between Mar 4, 2024 and Jul 3, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE CONSEQUENCES REPORTED. NINE STERILE SAMPLES ARE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394507 ↗
• MalfunctionMar 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE SURGERY ON (B)(6) 2024, AND BARBED SUTURE WAS USED. THE SUTURES HAD BEEN FREEING AND BREAKING BY THE NEEDLE. AFTER A FOUR MINUTE DELAY, THE PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM OR ANY OTHER ISSUES. FURTHER INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832542 ↗
• MalfunctionMar 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE SURGERY ON (B)(6) 2024, AND BARBED SUTURE WAS USED. THE SUTURES HAD BEEN FREEING AND BREAKING BY THE NEEDLE. AFTER A FOUR MINUTE DELAY, THE PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM OR ANY OTHER ISSUES. FURTHER INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832521 ↗
• MalfunctionMar 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE SURGERY ON (B)(6) 2024, AND BARBED SUTURE WAS USED. THE SUTURES HAD BEEN FREEING AND BREAKING BY THE NEEDLE. AFTER A FOUR MINUTE DELAY, THE PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM OR ANY OTHER ISSUES. FURTHER INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832497 ↗
• MalfunctionMar 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE SURGERY ON (B)(6) 2024, AND BARBED SUTURE WAS USED. THE SUTURES HAD BEEN FREEING AND BREAKING BY THE NEEDLE. AFTER A FOUR MINUTE DELAY, THE PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM OR ANY OTHER ISSUES. FURTHER INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832478 ↗
• MalfunctionMar 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE SURGERY ON (B)(6) 2024, AND BARBED SUTURE WAS USED. THE SUTURES HAD BEEN FREEING AND BREAKING BY THE NEEDLE. AFTER A FOUR MINUTE DELAY, THE PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM OR ANY OTHER ISSUES. FURTHER INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832449 ↗