STRATAFIX SXMP2B411Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031464407), received between Aug 13, 2024 and May 12, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Degrade” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K192580); they may or may not involve this specific model.

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. POST-OP, A BLOOD BLISTER/SUTURE ABSCESS WAS NOTED APPROXIMATELY THREE MONTHS AFTER THE SURGERY. THE PATIENT UNDERWENT A SUPERFICIAL I&D. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Blister

  MAUDE report 25149222 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. POST-OP, A BLOOD BLISTER/SUTURE ABSCESS WAS NOTED APPROXIMATELY THREE MONTHS AFTER THE SURGERY. ON (B)(6) 2026, A WASHOUT PROCEDURE WAS PERFORMED. IT WAS FURTHER REPORTED THAT ANOTHER ABSCESS/BLOOD BLISTER SUBSEQUENTLY FORMED. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Blister; Unspecified Infection

  MAUDE report 25000127 ↗
• 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 24904099 ↗
• 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 24897213 ↗
• 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 24-SEPT-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 24897189 ↗
• MalfunctionApr 15, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA ON AN UNKNOWN DATE AND IN DEC 2025 OR JAN 2026 OVER THE PAST TWO MONTHS, THE PATIENT EXPERIENCED A SKIN REACTION THAT WAS ATTRIBUTED TO THE POLYMER MATERIAL OF THE SUTURE, OCCURRING APPROXIMATELY FIVE TO SIX WEEKS POST-PROCEDURE. ALL DEVICES INVOLVED WERE DISCARDED AND ARE NOT AVAILABLE FOR RETURN OR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Local Reaction; Rash; Skin Inflammation/ Irritation

  MAUDE report 24889589 ↗
• MalfunctionApr 15, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA ON AN UNKNOWN DATE AND IN (B)(6) 2025 OR (B)(6) 2026 OVER THE PAST TWO MONTHS, THE PATIENT EXPERIENCED A SKIN REACTION THAT WAS ATTRIBUTED TO THE POLYMER MATERIAL OF THE SUTURE, OCCURRING APPROXIMATELY FIVE TO SIX WEEKS POST-PROCEDURE. ALL DEVICES INVOLVED WERE DISCARDED AND ARE NOT AVAILABLE FOR RETURN OR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Local Reaction; Rash; Skin Inflammation/ Irritation

  MAUDE report 24889587 ↗
• MalfunctionApr 15, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA ON AN UNKNOWN DATE AND IN DEC 2025 OR JAN 2026 OVER THE PAST TWO MONTHS, THE PATIENT EXPERIENCED A SKIN REACTION THAT WAS ATTRIBUTED TO THE POLYMER MATERIAL OF THE SUTURE, OCCURRING APPROXIMATELY FIVE TO SIX WEEKS POST-PROCEDURE. ALL DEVICES INVOLVED WERE DISCARDED AND ARE NOT AVAILABLE FOR RETURN OR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Local Reaction; Rash; Skin Inflammation/ Irritation

  MAUDE report 24889582 ↗
• MalfunctionApr 15, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA ON AN UNKNOWN DATE AND IN (B)(6) 2025 OR (B)(6) 2026 OVER THE PAST TWO MONTHS, THE PATIENT EXPERIENCED A SKIN REACTION THAT WAS ATTRIBUTED TO THE POLYMER MATERIAL OF THE SUTURE, OCCURRING APPROXIMATELY FIVE TO SIX WEEKS POST-PROCEDURE. ALL DEVICES INVOLVED WERE DISCARDED AND ARE NOT AVAILABLE FOR RETURN OR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Local Reaction; Rash; Skin Inflammation/ Irritation

  MAUDE report 24889579 ↗
• MalfunctionNov 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE SURGEON TOOK THE FIRST PASS, THE SUTURE AND NEEDLE BROKE. IT WAS FURTHER DESCRIBED THAT THE NEEDLE AND SUTURE WERE DETACHED WHERE THEY MEET. THE NEEDLE DID NOT FALL INTO THE PATIENT. THE NEEDLE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH A NEW SUTURE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20637362 ↗
• MalfunctionNov 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE SURGEON TOOK THE FIRST PASS, THE SUTURE AND NEEDLE BROKE. IT WAS FURTHER DESCRIBED THAT THE NEEDLE AND SUTURE WERE DETACHED WHERE THEY MEET. THE NEEDLE DID NOT FALL INTO THE PATIENT. THE NEEDLE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH A NEW SUTURE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20635140 ↗
• MalfunctionSep 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT WHILE CLOSING THE SUBCUTANEOUS OF FIVE TOTAL KNEE REPLACEMENT PROCEDURE THAT THE SUTURE FEELS LIKE IT IS A "POPOFF" AND THE NEEDLE COMES OFF THE SUTURE AT THE SWEDGE. TWO OF THE PROCEDURES DID NOT NEED ADDITIONAL SUTURE TO COMPLETE THE PROCEDURE BUT THREE OF THEM NEEDED TO OPEN A SECOND DEVICE TO FINISH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190858 ↗
• MalfunctionSep 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT WHILE CLOSING THE SUBCUTANEOUS OF FIVE TOTAL KNEE REPLACEMENT PROCEDURE THAT THE SUTURE FEELS LIKE IT IS A "POPOFF" AND THE NEEDLE COMES OFF THE SUTURE AT THE SWEDGE. TWO OF THE PROCEDURES DID NOT NEED ADDITIONAL SUTURE TO COMPLETE THE PROCEDURE BUT THREE OF THEM NEEDED TO OPEN A SECOND DEVICE TO FINISH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190757 ↗
• MalfunctionSep 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT WHILE CLOSING THE SUBCUTANEOUS OF FIVE TOTAL KNEE REPLACEMENT PROCEDURE THAT THE SUTURE FEELS LIKE IT IS A "POPOFF" AND THE NEEDLE COMES OFF THE SUTURE AT THE SWEDGE. TWO OF THE PROCEDURES DID NOT NEED ADDITIONAL SUTURE TO COMPLETE THE PROCEDURE BUT THREE OF THEM NEEDED TO OPEN A SECOND DEVICE TO FINISH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190738 ↗
• MalfunctionSep 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT WHILE CLOSING THE SUBCUTANEOUS OF FIVE TOTAL KNEE REPLACEMENT PROCEDURE THAT THE SUTURE FEELS LIKE IT IS A "POPOFF" AND THE NEEDLE COMES OFF THE SUTURE AT THE SWEDGE. TWO OF THE PROCEDURES DID NOT NEED ADDITIONAL SUTURE TO COMPLETE THE PROCEDURE BUT THREE OF THEM NEEDED TO OPEN A SECOND DEVICE TO FINISH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190619 ↗
• MalfunctionSep 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT WHILE CLOSING THE SUBCUTANEOUS OF FIVE TOTAL KNEE REPLACEMENT PROCEDURE THAT THE SUTURE FEELS LIKE IT IS A "POPOFF" AND THE NEEDLE COMES OFF THE SUTURE AT THE SWEDGE. TWO OF THE PROCEDURES DID NOT NEED ADDITIONAL SUTURE TO COMPLETE THE PROCEDURE BUT THREE OF THEM NEEDED TO OPEN A SECOND DEVICE TO FINISH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190601 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE HALFWAY UP ON THE NEEDLE ON THE SECOND PASS. THEY CONTINUED TO USE IT FOR THAT SAME SIDE AND GOT ANOTHER ONE TO COMPLETE THE TOTAL KNEE PROCEDURE WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974324 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE HALFWAY UP ON THE NEEDLE ON THE SECOND PASS. THEY CONTINUED TO USE IT FOR THAT SAME SIDE AND GOT ANOTHER ONE TO COMPLETE THE TOTAL KNEE PROCEDURE WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974300 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192580. One submission often covers many models, so check the product and lot details in each record.

• Z-1533-2024 · Mar 8, 2024 · Open, Classified
  STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft