STRATAFIX SXPP1B113Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 10705031236295), received between Oct 10, 2018 and Sep 16, 2026 — classified as 26 injuries, 105 malfunctions.

The most frequently reported specific device problem is “Break” (81 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 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789796 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50285442 ↗
• MalfunctionAug 5, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50143111 ↗
• MalfunctionJul 7, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. NEEDLE AND THREAD SEPARATED DURING USE. THE REPORTED ISSUE DID NOT RESULT IN ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25735780 ↗
• MalfunctionJun 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING C-SECTION, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548679 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLECTOMY ON (B)(6) 2026 AND A BARBED SUTURE WAS USED ON THE DERMIS. THE PATIENT EXPERIENCED A POSTOPERATIVE WOUND OPENING AFTER USING THE BARBED SUTURE IN AN INFECTION CASE. THE DOCTOR OPINED THAT IT WAS ORIGINALLY AN INFECTIOUS DISEASE CASE AND THERE WAS NO CAUSAL RELATIONSHIP WITH THE BARBED SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 25474139 ↗
• MalfunctionApr 29, 2026Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN OB-GYN SURGERY, THERE WAS NO LOOP WHEN THE PRODUCT WAS CHECKED BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035825 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER'S STITCHES BROKE WHILE USING OUR PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25032992 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER'S STITCHES BROKE WHILE USING OUR PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED. SFXSPI PDS+ UNI VIO 18IN 4-0 SA PS-2 PMP (SXPP1B113): UNKNOWN. SFXSPI PDS+ UNI VIO 18IN 4-0 SA PS-2 PMP (SXPP1B113): LOT CODE/LOT CODE: 100XJU. LIST OF OTHER J&J PRODUCTS (NON-CUSTOMER COMPLAINT PRODUCTS) USED IN THE CASE SURGERY. HAS THERE BEEN A PATIENT OR USER INJURY REPORT? NO. ARE THERE ANY NOTICEABLE DELAYS? NO. IF AVAILABLE, PROVIDE THE PRODUCT ORDER NUMBER (PO).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25032401 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING SURGERY THE NEEDLE AT THE SWAGE PART WAS BROKEN. IT HAS BEEN CONFIRMED THAT NO PIECES WERE LEFT INSIDE THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808783 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING TOTAL KNEE ARTHROPLASTY, THE SUTURE BROKE WHEN THE KNEE WAS BENT AFTER SUTURING. THE PRODUCT WAS USED ON THE DERMIS. THIS ISSUE OCCURRED DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627203 ↗
• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE DOCTOR PASSED THE NEEDLE THROUGH THE LOOP, THE LOOP CAME UNTIED. THIS ISSUE OCCURRED DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617764 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24418662 ↗
• MalfunctionFeb 20, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING OPEN ABDOMINAL TOTAL HYSTERECTOMY, THE DOCTOR TRIED TO START SUTURING BY PASSING THE NEEDLE THOUGH THE LOOP, BUT TEMPORARY FIXING COULD NOT BE DONE, AND THE DOCTOR COULD NOT SUTURE. THE PRODUCT WAS USED ON THE DERMIS. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402685 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24084381 ↗
• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SEMI OPEN RIGHT VIDEO-ASSISTED THORACOSCOPIC SURGERY LOBECTOMY (BULLECTOMY (WEDGE RESECTION) FOR LUNG CANCER PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING SEMI OPEN RIGHT VIDEO-ASSISTED THORACOSCOPIC SURGERY LOBECTOMY (BULLECTOMY (WEDGE RESECTION) FOR LUNG CANCER, IT WAS FOUND BY THE OPERATING ROOM STAFF BEFORE USING THE PRODUCT THAT WHEN THE PRODUCT WAS OPENED AND TRIED TO USE, THE SUTURE WAS BROKEN. THE PRODUCT WAS USED ON THE HYPODERMIS. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936101 ↗
• MalfunctionDec 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DECOMPRESSION AND FIXATION SURGERY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED ON THE L3-5 VERTEBRAE. DURING THE PROCEDURE, THE SUTURE WAS BROKEN FROM THE NEEDLE LIKE A CONTROL RELEASE NEEDLE-SUTURE AT THE 2ND STITCH DURING USE. THE DOCTOR SUTURED AGAIN TO FINISH THE WOUND CLOSURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935108 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING C-SECTION, THE SUTURE WAS DETACHED FROM THE NEEDLE. THE PRODUCT WAS USED ON THE DERMIS. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840117 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING TOTAL KNEE ARTHROPLASTY, THE OPERATING ROOM NURSE REPORTED THAT DURING USE, THE CONNECTION PART BETWEEN THE NEEDLE AND THE SUTURE WERE DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790835 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THERE HAD BEEN NO LOOP. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086170 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE LOOP WAS BROKEN WHEN STARTED TO USE IT AND THE SUTURE WAS BROKEN DURING USE. USE WAS STOPPED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22703712 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING A TOTAL HIP ARTHROPLASTY, THE SUTURE WAS BROKEN DURING DERMOSTITCH. THE PRODUCT WAS USED ON THE DERMIS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE CUT PART WAS LIGATED AND ADDITIONAL SUTURE THAT THE REMAINING SKIN INCISION WAS SUTURED WITH ANOTHER SUTURE TO COMPLETE THE CASE. THE POSTOPERATIVE COURSE WAS UNEVENTFUL AFTER THE SURGERY. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060409 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE BROKE HALFWAY THROUGH USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860104 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNI-COMPARTMENTAL KNEE ARTHROPLASTY (UKA) ON AN UNKNOWN DATE IN (B)(6) 2025 AND A BARBED SUTURE WAS USED ON THE DERMIS. DURING THE PROCEDURE, A DIFFERENT SUTURE WAS USED ON THE SUBCUTANEOUS. WITHIN 2 WEEKS AFTER THE SURGERY, THE DERMIS WOUND DEHISCENCE OCCURRED ONCE BEFORE THE PATIENT WAS DISCHARGED. AT THAT TIME, AN ADDITIONAL SUTURE WAS PERFORMED WITH NYLON. THE SURGEON OPINED THAT THE BARBED SUTURE WAS NOT AT FAULT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21730383 ↗
• MalfunctionMar 11, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION (C-SECTION) ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED FOR DERMIS SUTURING. THE BARB WAS NOT HOOKED ENOUGH, AND THE SUTURE WAS TURNED BACK EVEN WHEN SUTURING. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580369 ↗