STRATAFIX SXPP2B412Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10705031464520), received between Nov 21, 2023 and Jun 10, 2026 — classified as 4 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Material Separation” (27 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE IS POPPING OFF OF THE SUTURE. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25457311 ↗
• MalfunctionJun 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE IS POPPING OFF OF THE SUTURE. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25457310 ↗
• MalfunctionJun 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE IS POPPING OFF OF THE SUTURE. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25457306 ↗
• MalfunctionJun 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE IS POPPING OFF OF THE SUTURE. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25457305 ↗
• MalfunctionMay 21, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING UNKNOWN PROCEDURE THE IMPLANT COORDINATOR IN THE OPERATING ROOM REPORTED RECEIVING EMPTY PRODUCT PACKAGES AND WAS INFORMED THAT THE STRATAFIX SUTURES HAD BEEN DETACHING FROM THE NEEDLE (NEEDLE ¿POP-OFF¿ ISSUE) DURING USE. NO PATIENT CONSEQUENCES. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240738 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC JOINT PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE PRODUCT BROKE DURING THE OPERATION. THE BARBED SUTURE WAS BEING USED IN CLOSURE. IT¿S UNKNOWN WHAT LAYER THE SUTURE WAS BEING USED IN. THE PROCEDURE WAS DELAYED 25 MINUTES DUE TO THE REPORTED EVENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924729 ↗
• MalfunctionApr 16, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. POST-OP ON (B)(6) 2026, THE BARBED SUTURE MIGRATED AWAY FROM THE INCISION AND EXITED THROUGH THE SKIN MEDIAL TO THE INCISION SITE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 24897215 ↗
• MalfunctionApr 16, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. POST-OP, ON (B)(6) 2026, THE BARBED SUTURE MIGRATED AWAY FROM THE INCISION AND EXITED THROUGH THE SKIN MEDIAL TO THE INCISION SITE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 24897200 ↗
• MalfunctionApr 16, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR TOTAL HIP REPLACEMENT ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE SUTURE WAS NOT ABSORBING AND MIGRATED FROM THE INCISION. THE PATIENT WAS ABLE TO EXTRACT THE WHOLE SUTURE FROM THE INNER PART OF HER THIGH 4-5 WEEKS POST OPERATION. IT WAS REPORTED THAT (B)(6) 2025, WAS WHEN THE SUTURE WAS MIGRATING AND THE PATIENT REPORTED IT TO THE PHYSICIAN. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 24897187 ↗
• MalfunctionSep 19, 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, THE NEEDLE KEPT POPPING OFF WHEN THEY WERE RUNNING THE STITCH. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096539 ↗
• MalfunctionAug 12, 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, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THE NEEDLE KEEP POPPING OFF WHEN THEY WERE RUNNING THE STITCH. NO PATIENT HARM REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782365 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED BY THE SURGEON THAT THE SUTURE BROKE IN HALF WHILE BEING USED INTRA-OP. DEVICES WERE RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633135 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED BY THE SURGEON THAT THE SUTURE BROKE IN HALF WHILE BEING USED INTRA-OP. DEVICES WERE RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633134 ↗
• MalfunctionFeb 5, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL JOINT PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT STARTED TO EXPERIENCE TRACTS AND THE SUTURE NOT ABSORBING AFTER 6+ WEEKS WHILE SPITTING FROM THE PATIENT AROUND THE INCISION AREA. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Pocket Erosion

  MAUDE report 21311980 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITHIN THE LAST 18 MONTHS AND A BARBED SUTURE WAS USED. POST-OP, THE PRODUCT WAS SPITTING. THE PATIENT RETURNED WITH PROBLEMS. THE DRESSING WAS CHANGED AND THE PATIENT CONTINUED TO RETURN. THE DOCTOR IS NOT SURE WHAT THE ISSUE WAS. IT HAS BEEN NARROWED DOWN TO ISSUES WITH THE BARBED SUTURE. THE SKIN SPITTING OUT, THE BAR IN THE WOUND WHERE THE REACTION IS OCCURRING. THE DOCTOR TRIED RUBBING IT, AND TEN DAYS TO TWO WEEKS LATER, IT DISSOLVED. WITHIN TWO TO THREE WEEKS, THE PATIENT WAS UNCOMFORTABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Local Reaction; Pocket Erosion

  MAUDE report 21231851 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITHIN THE LAST 18 MONTHS AND A BARBED SUTURE WAS USED. POST-OP, THE PRODUCT WAS SPITTING. THE PATIENT RETURNED WITH PROBLEMS. THE DRESSING WAS CHANGED AND THE PATIENT CONTINUED TO RETURN. THE DOCTOR IS NOT SURE WHAT THE ISSUE WAS. IT HAS BEEN NARROWED DOWN TO ISSUES WITH THE BARBED SUTURE. THE SKIN SPITTING OUT, THE BAR IN THE WOUND WHERE THE REACTION IS OCCURRING. THE DOCTOR TRIED RUBBING IT, AND TEN DAYS TO TWO WEEKS LATER, IT DISSOLVED. WITHIN TWO TO THREE WEEKS, THE PATIENT WAS UNCOMFORTABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Local Reaction; Pocket Erosion

  MAUDE report 21231850 ↗
• MalfunctionJan 7, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL JOINT PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. POST-OP,, SALES REP IS REPORTING FROM THE CUSTOMER THAT FOLLOWING A TOTAL JOINT PROCEDURE A PATIENT STARTED TO EXPERIENCE "TRACS" AND THE SUTURE NOT ABSORBING AFTER 5 WEEKS WHILE SPITTING FROM THE PATIENT AROUND THE INCISION AREA. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Pocket Erosion

  MAUDE report 21097888 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING AN UNKNOWN ORTHOPEDIC PROCEDURE THAT WHILE SUTURING THE SUBCUTICULAR LAYER OF TISSUE TWO SUTURES BROKE AROUND THE MIDDLE OF THE SUTURE. ANOTHER LIKE SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854469 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED TO THE SALES REP THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE THAT WHILE SUTURING THE SUBCUTICULAR LAYER OF TISSUE TWO SUTURES BROKE AROUND THE MIDDLE OF THE SUTURE. ANOTHER LIKE SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. TWO SUTURES RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854217 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND BARBED SUTURE WAS USED. THE SUTURE SNAPPED IN HALF. NO ADDITIONAL INFO WAS GIVEN TO THE REP. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759571 ↗
• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE SUTURE BROKE DURING THE PROCEDURE. IT ENDED UP BREAKING AFTER TRYING TO PULL THROUGH AND TIGHTENING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE CASE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20290352 ↗
• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE SUTURE BROKE DURING THE PROCEDURE. AS THE GOT TO THE DISTAL END TO DO TWO BACK PASSES AND IT SNAPPED. ANOTHER LIKE DEVICE WAS USED TO CONTINUE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20290279 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE IN THE MIDDLE OF THE CASE DURING THE PASSING. THEY GOT ANOTHER SUTURE TO COMPLETE THE CASE WITHOUT ANY PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19649239 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THEY WERE TAKING THE FIRST PASS THROUGH THE TRANSITION POINT AND THE SUTURE BROKE. THEY GOT ANOTHER SUTURE TO FINISH THE REST OF THE PROCEDURE WITHOUT PATIENT HARM. THE PRODUCT USED WAS DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632614 ↗
• MalfunctionJun 26, 2024Material Frayed; Material Frayed

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE SUTURE/NEEDLE MEETING POINT THE SUTURE LOOKS FRAYED. THEY WERE ABLE TO COMPLETE THE REST OF THE CASE WITH A NEW ONE WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19614463 ↗