STRATAFIX SXMP1B414Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10705031236400), received between Jan 29, 2018 and Aug 5, 2026 — classified as 5 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Material Separation” (15 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50144218 ↗
• MalfunctionJul 29, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50067359 ↗
• MalfunctionJul 29, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50067342 ↗
• MalfunctionJul 29, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50067330 ↗
• MalfunctionMar 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE NEEDLE DETACHED FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24485002 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE REPLACEMENT PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT, THE NEEDLES POPPED OFF THE SUTURE IN TWO CONSECUTIVE CASES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790615 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE REPLACEMENT PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT, THE NEEDLES POPPED OFF THE SUTURE IN TWO CONSECUTIVE CASES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790611 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE REPLACEMENT PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT, THE NEEDLES POPPED OFF THE SUTURE IN TWO CONSECUTIVE CASES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790348 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE REPLACEMENT PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT, THE NEEDLES POPPED OFF THE SUTURE IN TWO CONSECUTIVE CASES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790346 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE FIXED BEARING CEMENTED PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING SUBCUTANEOUS LAYER DURING A KNEE FIXED BEARING CEMENTED PROCEDURE WITH STRATAFIX SPIRAL MONOCRYL PLUS, THE SUTURE THREAD BROKE PROBABLY RELATED TO THE SURGEON APPLYING TOO MUCH TENSION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? NO, WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303717 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE ARTHROSCOPY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE SNAPPED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663387 ↗
• InjuryMar 10, 2025Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT'S SKIN INCISION POPPED OPEN AND THEY HAD TO DO A WASH OUT AND REVISE THE SKIN CLOSURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21564104 ↗
• MalfunctionFeb 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE LOOSENED FOR THE THREAD ON TWO CASES IN THE SAME PROCEDURE. NO EXTRA FORCE OR TENSION WAS APPLIED, AND THE SURGEON WAS SURPRISED HOW EASILY IT LOOSENED, AS IT NORMALLY NEVER DOES. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421255 ↗
• MalfunctionFeb 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE LOOSENED FOR THE THREAD ON TWO CASES IN THE SAME PROCEDURE. NO EXTRA FORCE OR TENSION WAS APPLIED, AND THE SURGEON WAS SURPRISED HOW EASILY IT LOOSENED, AS IT NORMALLY NEVER DOES. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421252 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON (B)(6) 2024 AND SUTURE WAS USED. PRIOR TO USE, WHEN THEY PULLED THE SUTURE OUT OF THE PACKET THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. UPON EVALUATION OF THE RETURNED DEVICE, AN INCORRECT SWAGE DEFECT WAS IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181447 ↗
• MalfunctionAug 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP, THAT DURING A TOTAL KNEE RECONSTRUCTION, THE SUTURE BROKE OFF AT THE NEEDLE. OPENED A NEW ONE TO COMPLETE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992264 ↗
• MalfunctionMar 7, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2024, AND BARBED SUTURE WAS USED. SEVERAL STRATAFIX MONOCRYL SUTURES SNAPPED MID SUTURE LINE. SUTURES OF DIFFERENT SIZES, SEVERAL 3-0 AND 2-0 SUTURES. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861630 ↗
• MalfunctionMar 7, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2024, AND BARBED SUTURE WAS USED. SEVERAL STRATAFIX MONOCRYL SUTURES SNAPPED MID SUTURE LINE. SUTURES OF DIFFERENT SIZES, SEVERAL 3-0 AND 2-0 SUTURES. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861427 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL TOTAL KNEE ARTHROPLASTY ON (B)(6)2023 AND BARBED SUTURE WAS USED FOR CLOSURE OF THE JOINT CAPSULE AND CLOSURE OF THE SUBCUTANEOUS LAYER OF THE LEFT KNEE. THE FOLLOWING DAY, 16-NOV-2023, THE PATIENT FALLS AND PERFORMS A FORCED FLEXION OF BOTH KNEES CAUSING THE TRAUMATIC OPENING OF THE LEFT KNEE, THE PATIENT IS BROUGHT BACK THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 18292436 ↗
• MalfunctionDec 21, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6)2022 AND A BARBED SUTURE WAS USED. DURING CLOSURE ON THE INITIAL PASS, THE NEEDLE PULLED OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022303 ↗
• MalfunctionDec 21, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2022 AND A BARBED SUTURE WAS USED. DURING CLOSURE ON THE INITIAL PASS, THE NEEDLE PULLED OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022254 ↗
• MalfunctionDec 9, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT ATOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING USE, WHILE IN A TOTAL KNEE REPLACEMENT AND USING SUTURE, THE NEEDLE POPPED OFF. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949063 ↗
• MalfunctionDec 9, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT ATOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING USE, WHILE IN A TOTAL KNEE REPLACEMENT AND USING SUTURE, THE NEEDLE POPPED OFF. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949057 ↗
• MalfunctionDec 9, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING USE, WHILE IN A TOTAL KNEE REPLACEMENT AND USING SUTURE, THE NEEDLE POPPED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949053 ↗
• MalfunctionDec 9, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING USE, WHILE IN A TOTAL KNEE REPLACEMENT AND USING SUTURE, THE NEEDLE POPPED OFF. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949050 ↗