STRATAFIX SXMP1B113Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031236721), received between Feb 26, 2018 and May 19, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Degrade” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionMay 19, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHERE THE STRATAFIX MONOCRYL WAS STILL PRESENT AFTER 4 MONTHS AND HAD TO BE REMOVED BY SURGEON. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 25222826 ↗
• MalfunctionMay 1, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHERE THE STRATAFIX MONOCRYL WAS STILL PRESENT AFTER 4 MONTHS AND HAD TO BE REMOVED BY SURGEON. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 25058708 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DR. (B)(6) UNDERWENT A LEFT TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED TO CLOSE THE SKIN. THE PATIENT THEN EXPERIENCED A STRONG WOUND REACTION WHICH HAS ONLY JUST SETTLED DOWN. THE PATIENT HAS SUBSEQUENTLY UNDERGONE A R TKR AND THE SURGEON USED A DIFFERENT SUTURE TO CLOSE THE SKIN WITH FAR FEWER PROBLEMS. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? NO, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS?-YES DETAILS TO FOLLOW. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blister; Fluid Discharge; Itching Sensation; Local Reaction

  MAUDE report 15089259 ↗
• MalfunctionMay 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SCOLIOSIS STRAIGHTENING PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBED SUTURE WAS PASSED THROUGH THE SKIN AND THE NEEDLE CAME FREE FROM THE BARBED SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11815015 ↗
• MalfunctionMar 4, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN KNEE PROCEDURE ON (B)(6) 2020 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED WITH VERY MINIMAL FORCE APPLIED ABOUT HALF WAY THROUGH CLOSING SKIN OF A KNEE. THE SURGEON USED ANOTHER OF THE SAME SUTURE, BUT STARTED AT THE OPPOSITE APEX OF THE WOUND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9787266 ↗
• InjuryFeb 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. POST OPERATIVELY, ONE DAY AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH WOUND DEHISCENCE. THE CLOSURES ARE DONE BY THE PA FROM CAPSULE TO SKIN. ADDITIONAL INFORMATION FROM THE SURGEON INDICATES THAT THE PA WAS NOT GOING AS DEEP WITH THE DEEP DERMAL BITES AND HAD AN ERROR IN USAGE AND DOES NOT OPINE THAT THERE WAS ANY PRODUCT FAILURE. THE DEHISCENCE WAS MOST LIKELY SUBCUTICULAR AND NOT DEEPER. THE WOUND WAS RE-SUTURED CLOSED IN THE OFFICE AND THE PATIENTS CURRENT CONDITION IS FINE.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 7296439 ↗