STRATAFIX SXPP2B435Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031465138), received between Sep 8, 2023 and Sep 15, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE THAT THE SUTURE WAS "SLIDING" AND THAT THE BARBS WERE NOT CATCHING. A SECOND SUTURE FROM THE SAME LOT WAS OPENED WHICH PRESENTED WITH THE SAME ISSUE. A THIRD FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. TWENTY-EIGHT STERILE SAMPLES WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756525 ↗
• MalfunctionSep 15, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE THAT THE SUTURE WAS "SLIDING" AND THAT THE BARBS WERE NOT CATCHING. A SECOND SUTURE FROM THE SAME LOT WAS OPENED WHICH PRESENTED WITH THE SAME ISSUE. A THIRD FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. TWENTY-EIGHT STERILE SAMPLES WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756524 ↗
• MalfunctionSep 8, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6)2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT 'SLIPPING.' A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17713050 ↗
• MalfunctionSep 8, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT 'SLIPPING.' A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17713048 ↗