STRATAFIX SXPP1B202Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031235977), received between Jun 1, 2022 and Jun 1, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROSTHESIS SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE SUTURE UNDER THE SKIN RETURNED TO THE SURFACE OF THE SKIN CREATING AN INFECTIOUS. THE PATIENT UNDERWENT SCAR REVISION WITH THE REMOVAL OF THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Necrosis; Pocket Erosion; Unspecified Infection

  MAUDE report 14567602 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROSTHESIS SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE SUTURE UNDER THE SKIN RETURNED TO THE SURFACE OF THE SKIN CREATING AN INFECTIOUS. THE PATIENT UNDERWENT SCAR REVISION WITH THE REMOVAL OF THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Necrosis; Pocket Erosion; Sepsis; Unspecified Infection

  MAUDE report 14567597 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROSTHESIS SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE SUTURE UNDER THE SKIN RETURNED TO THE SURFACE OF THE SKIN CREATING AN INFECTIOUS. THE PATIENT UNDERWENT SCAR REVISION WITH THE REMOVAL OF THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Necrosis; Pocket Erosion; Unspecified Infection

  MAUDE report 14567590 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROSTHESIS SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE SUTURE UNDER THE SKIN RETURNED TO THE SURFACE OF THE SKIN CREATING AN INFECTIOUS. THE PATIENT UNDERWENT SCAR REVISION WITH THE REMOVAL OF THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fistula; Necrosis; Pocket Erosion; Sepsis; Unspecified Infection

  MAUDE report 14567587 ↗
• InjuryJun 1, 2022Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROSTHESIS SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE SUTURE UNDER THE SKIN RETURNED TO THE SURFACE OF THE SKIN CREATING AN INFECTIOUS. THE PATIENT UNDERWENT SCAR REVISION WITH THE REMOVAL OF THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 14567586 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROSTHESIS SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE SUTURE UNDER THE SKIN RETURNED TO THE SURFACE OF THE SKIN CREATING AN INFECTIOUS. THE PATIENT UNDERWENT SCAR REVISION WITH THE REMOVAL OF THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Necrosis; Pocket Erosion; Unspecified Infection

  MAUDE report 14567584 ↗
• InjuryJun 1, 2022Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROSTHESIS SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE SUTURE UNDER THE SKIN RETURNED TO THE SURFACE OF THE SKIN CREATING AN INFECTIOUS. THE PATIENT UNDERWENT SCAR REVISION WITH THE REMOVAL OF THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 14567583 ↗
• InjuryJun 1, 2022Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROSTHESIS SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE SUTURE UNDER THE SKIN RETURNED TO THE SURFACE OF THE SKIN CREATING AN INFECTIOUS. THE PATIENT UNDERWENT SCAR REVISION WITH THE REMOVAL OF THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 14567581 ↗