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STRATAFIX SXMP2B409Recalls & reported problems

Ethicon, LLC · Stratafix (Spiral MONOCRYL Plus), Bidirectional · Class 2 · Implant

All models of STRATAFIX (181)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Ethicon Stratafix absorbable barbed suture is used to close surgical incisions. Reports mostly describe the suture material separating or breaking, not dissolving as expected, and migrating out through the skin weeks after knee or hip surgery, along with skin irritation and slow healing. There are 31 reports, with4 injuries and no deaths. Reports have risen from 9 to 19 in the past 12 months, and no recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
31
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10705031464278), received between Jun 18, 2024 and May 21, 2026 — classified as 4 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Material Separation” (14 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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 2 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 5 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 4 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 10 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 7 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202610
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Separation14
  • Failure to Degrade7
  • Adverse Event Without Identified Device or Use Problem4
  • Positioning Failure4
  • Break2

Patient problems

  • No Clinical Signs, Symptoms or Conditions20
  • Impaired Healing4
  • Local Reaction4
  • Rash4
  • Skin Inflammation/ Irritation4
  • Pocket Erosion3

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

  • 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 25240760 ↗
  • 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 24904088 ↗
  • 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 24897199 ↗
  • 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 24897190 ↗
  • 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 24889586 ↗
  • 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 24889584 ↗
  • 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 24889581 ↗
  • 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 24889578 ↗
  • MalfunctionFeb 5, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LOBECTOMY PROCEDURE ON (B)(6)2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24269854 ↗
  • MalfunctionJan 28, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DOCTOR THAT PRODUCT FAILED DURING SURGERY. SHE STATED THAT THE NEEDLES ON THE SUTURES KEPT BREAKING OFF. THEY ATTEMPTED TO USE 7 OUT OF THE 12 SUTURES IN THE BOX AND ALL 7 THE NEEDLES BROKE. THEY KEPT HAVING TO START OVER WITH THE SUTURES, WHICH HAD AN IMPACT ON THE PATIENT DUE TO NEEDING TO REMOVE AND RESTART THE SUTURE PROCESS. THE CUSTOMER IS REQUESTING TO RETURN AND REPLACE THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24202754 ↗
  • MalfunctionJan 28, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DOCTOR THAT PRODUCT FAILED DURING SURGERY. SHE STATED THAT THE NEEDLES ON THE SUTURES KEPT BREAKING OFF. THEY ATTEMPTED TO USE 7 OUT OF THE 12 SUTURES IN THE BOX AND ALL 7 THE NEEDLES BROKE. THEY KEPT HAVING TO START OVER WITH THE SUTURES, WHICH HAD AN IMPACT ON THE PATIENT DUE TO NEEDING TO REMOVE AND RESTART THE SUTURE PROCESS. THE CUSTOMER IS REQUESTING TO RETURN AND REPLACE THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24202744 ↗
  • MalfunctionJan 28, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DOCTOR THAT PRODUCT FAILED DURING SURGERY. SHE STATED THAT THE NEEDLES ON THE SUTURES KEPT BREAKING OFF. THEY ATTEMPTED TO USE 7 OUT OF THE 12 SUTURES IN THE BOX AND ALL 7 THE NEEDLES BROKE. THEY KEPT HAVING TO START OVER WITH THE SUTURES, WHICH HAD AN IMPACT ON THE PATIENT DUE TO NEEDING TO REMOVE AND RESTART THE SUTURE PROCESS. THE CUSTOMER IS REQUESTING TO RETURN AND REPLACE THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24202741 ↗
  • MalfunctionJan 28, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DOCTOR THAT PRODUCT FAILED DURING SURGERY. SHE STATED THAT THE NEEDLES ON THE SUTURES KEPT BREAKING OFF. THEY ATTEMPTED TO USE 7 OUT OF THE 12 SUTURES IN THE BOX AND ALL 7 THE NEEDLES BROKE. THEY KEPT HAVING TO START OVER WITH THE SUTURES, WHICH HAD AN IMPACT ON THE PATIENT DUE TO NEEDING TO REMOVE AND RESTART THE SUTURE PROCESS. THE CUSTOMER IS REQUESTING TO RETURN AND REPLACE THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24202740 ↗
  • MalfunctionJan 28, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DOCTOR THAT PRODUCT FAILED DURING SURGERY. SHE STATED THAT THE NEEDLES ON THE SUTURES KEPT BREAKING OFF. THEY ATTEMPTED TO USE 7 OUT OF THE 12 SUTURES IN THE BOX AND ALL 7 THE NEEDLES BROKE. THEY KEPT HAVING TO START OVER WITH THE SUTURES, WHICH HAD AN IMPACT ON THE PATIENT DUE TO NEEDING TO REMOVE AND RESTART THE SUTURE PROCESS. THE CUSTOMER IS REQUESTING TO RETURN AND REPLACE THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24202726 ↗
  • MalfunctionJan 28, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DOCTOR THAT PRODUCT FAILED DURING SURGERY. SHE STATED THAT THE NEEDLES ON THE SUTURES KEPT BREAKING OFF. THEY ATTEMPTED TO USE 7 OUT OF THE 12 SUTURES IN THE BOX AND ALL 7 THE NEEDLES BROKE. THEY KEPT HAVING TO START OVER WITH THE SUTURES, WHICH HAD AN IMPACT ON THE PATIENT DUE TO NEEDING TO REMOVE AND RESTART THE SUTURE PROCESS. THE CUSTOMER IS REQUESTING TO RETURN AND REPLACE THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24202698 ↗
  • MalfunctionJan 28, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DOCTOR THAT PRODUCT FAILED DURING SURGERY. SHE STATED THAT THE NEEDLES ON THE SUTURES KEPT BREAKING OFF. THEY ATTEMPTED TO USE 7 OUT OF THE 12 SUTURES IN THE BOX AND ALL 7 THE NEEDLES BROKE. THEY KEPT HAVING TO START OVER WITH THE SUTURES, WHICH HAD AN IMPACT ON THE PATIENT DUE TO NEEDING TO REMOVE AND RESTART THE SUTURE PROCESS. THE CUSTOMER IS REQUESTING TO RETURN AND REPLACE THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24202679 ↗
  • MalfunctionJan 23, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. I WAS INFORMED THAT DURING A CASE THE NEEDLE POPPED OFF OF 2 BARBED SUTURES. THEY POPPED OFF AFTER THE FIRST PASS. THE MATERIALS MANAGER OPENED A THIRD SUTURE OFF OF THE STERILE FIELD AND THE SAME THING HAPPENED, NEEDLE POPPED OFF WITH MINIMAL FORCE. THERE WAS NO PATIENT CONSEQUENCE AND NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO SIGNIFICANT DELAY. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24164808 ↗
  • MalfunctionJan 23, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. I WAS INFORMED THAT DURING A CASE THE NEEDLE POPPED OFF OF 2 BARBED SUTURES. THEY POPPED OFF AFTER THE FIRST PASS. THE MATERIALS MANAGER OPENED A THIRD SUTURE OFF OF THE STERILE FIELD AND THE SAME THING HAPPENED, NEEDLE POPPED OFF WITH MINIMAL FORCE. THERE WAS NO PATIENT CONSEQUENCE AND NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO SIGNIFICANT DELAY. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24164807 ↗
  • MalfunctionJan 23, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. I WAS INFORMED THAT DURING A CASE THE NEEDLE POPPED OFF OF 2 BARBED SUTURES. THEY POPPED OFF AFTER THE FIRST PASS. THE MATERIALS MANAGER OPENED A THIRD SUTURE OFF OF THE STERILE FIELD AND THE SAME THING HAPPENED, NEEDLE POPPED OFF WITH MINIMAL FORCE. THERE WAS NO PATIENT CONSEQUENCE AND NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO SIGNIFICANT DELAY. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24164806 ↗
  • InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED FOR SUBCUTICULAR CLOSURE. THE PATIENT DEVELOPED A STERILE NON-HEALING SURGICAL WOUND. AT THE 4-WEEK POST-OP VISIT, THE PATIENT WAS FOUND TO HAVE A NON-INFECTED, NON-HEALING INCISION. THE SURGEON OPINES THE TOPICAL SKIN ADHESIVE WITH MESH WAS THE ISSUE AS SHE HAD NOT SEEN THIS ON HER SHORTER INCISIONS CLOSED WITH JUST TOPICAL SKIN ADHESIVE. THE SURGEON HAS ALSO BEEN USING VANCOMYCIN POWDER, SUPRA-FASCIAL UP TO THE SKIN CLOSURE IN THE INCISIONS AS WELL. I&D OF THE INCISION WAS DONE.

    Patient problems: Impaired Healing

    MAUDE report 23319638 ↗
  • InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED FOR SUBCUTICULAR CLOSURE. THE PATIENT DEVELOPED A STERILE NON-HEALING SURGICAL WOUND. AT THE 4-WEEK POST-OP VISIT, THE PATIENT WAS FOUND TO HAVE A NON-INFECTED, NON-HEALING INCISION. THE SURGEON OPINES THE TOPICAL SKIN ADHESIVE WITH MESH WAS THE ISSUE AS SHE HAD NOT SEEN THIS ON HER SHORTER INCISIONS CLOSED WITH JUST TOPICAL SKIN ADHESIVE. THE SURGEON HAS ALSO BEEN USING VANCOMYCIN POWDER, SUPRA-FASCIAL UP TO THE SKIN CLOSURE IN THE INCISIONS AS WELL. I&D OF THE INCISION WAS DONE.

    Patient problems: Impaired Healing

    MAUDE report 23319637 ↗
  • InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED FOR SUBCUTICULAR CLOSURE. THE PATIENT DEVELOPED A STERILE NON-HEALING SURGICAL WOUND. AT THE 4-WEEK POST-OP VISIT, THE PATIENT WAS FOUND TO HAVE A NON-INFECTED, NON-HEALING INCISION. THE SURGEON OPINES THE TOPICAL SKIN ADHESIVE WITH MESH WAS THE ISSUE AS SHE HAD NOT SEEN THIS ON HER SHORTER INCISIONS CLOSED WITH JUST TOPICAL SKIN ADHESIVE. THE SURGEON HAS ALSO BEEN USING VANCOMYCIN POWDER, SUPRA-FASCIAL UP TO THE SKIN CLOSURE IN THE INCISIONS AS WELL. I&D OF THE INCISION WAS DONE.

    Patient problems: Impaired Healing

    MAUDE report 23319636 ↗
  • InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED FOR SUBCUTICULAR CLOSURE. THE PATIENT DEVELOPED A STERILE NON-HEALING SURGICAL WOUND. AT THE 4-WEEK POST-OP VISIT, THE PATIENT WAS FOUND TO HAVE A NON-INFECTED, NON-HEALING INCISION. THE SURGEON OPINES THE TOPICAL SKIN ADHESIVE WITH MESH WAS THE ISSUE AS SHE HAD NOT SEEN THIS ON HER SHORTER INCISIONS CLOSED WITH JUST TOPICAL SKIN ADHESIVE. THE SURGEON HAS ALSO BEEN USING VANCOMYCIN POWDER, SUPRA-FASCIAL UP TO THE SKIN CLOSURE IN THE INCISIONS AS WELL. I&D OF THE INCISION WAS DONE.

    Patient problems: Impaired Healing

    MAUDE report 23319635 ↗
  • MalfunctionNov 14, 2024Material Separation; Material Separation

    IT WAS REPORTED A PATIENT UNDERWENT AN TOTAL KNEE ARTHROSCOPY SURGERY ON AN UNKNOWN DATE IN 2024 AND BARBED SUTURE WAS USED. SURGEON EXPERIENCED SAME ISSUE WITH BARBED SUTURE BI DIRECTIONAL. NEEDLE POPPING OFF AND SUTURE SLIPPING UNABLE TO ADEQUATELY APPROXIMATE WOUND IN PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20689439 ↗
  • MalfunctionNov 14, 2024Material Separation; Material Separation

    IT WAS REPORTED A PATIENT UNDERWENT AN TOTAL KNEE ARTHROSCOPY SURGERY ON AN UNKNOWN DATE IN (B)(6)2024 AND BARBED SUTURE WAS USED. SURGEON EXPERIENCED SAME ISSUE WITH BARBED SUTURE BI DIRECTIONAL. NEEDLE POPPING OFF AND SUTURE SLIPPING UNABLE TO ADEQUATELY APPROXIMATE WOUND IN PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20689272 ↗

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

Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices

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Sources and updates

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