STRATAFIX SXPP2B101Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10705031464698), received between Jul 26, 2022 and Jun 17, 2026 — classified as 3 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (32 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE AT THE SWAGE PART EASILY. THE DOCTOR SAID THAT THE PRODUCT WAS USED AS USUAL, AND NO STRONG TRACTION WAS APPLIED. THE PRODUCT WAS USED ON THE DERMIS AND SPINE. 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 25535791 ↗
• MalfunctionMay 5, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN AT THE SWAGE PART AND THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING SUTURING. 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 25085944 ↗
• MalfunctionApr 28, 2026Break; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN BREAST AND ENDOCRINE SURGERY, THE DOCTOR FELT THAT THE SUTURE WAS A LITTLE LOOSE THAN USUAL. 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 25014903 ↗
• MalfunctionApr 28, 2026Break; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN BREAST AND ENDOCRINE SURGERY, THE DOCTOR FELT THAT THE SUTURE WAS A LITTLE LOOSE THAN USUAL. 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 25014844 ↗
• MalfunctionApr 28, 2026Break; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN BREAST AND ENDOCRINE SURGERY, THE DOCTOR FELT THAT THE SUTURE WAS A LITTLE LOOSE THAN USUAL. 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 25014842 ↗
• MalfunctionApr 28, 2026Break; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN BREAST AND ENDOCRINE SURGERY, THE DOCTOR FELT THAT THE SUTURE WAS A LITTLE LOOSE THAN USUAL. 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 25014839 ↗
• MalfunctionApr 28, 2026Break; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN BREAST AND ENDOCRINE SURGERY, THE DOCTOR FELT THAT THE SUTURE WAS A LITTLE LOOSE THAN USUAL. 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 25014769 ↗
• MalfunctionApr 27, 2026Break; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AND ENDOCRINE PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING SURGERY, THE DOCTOR FELT THAT THE SUTURE WAS A LITTLE LOOSE THAN USUAL. 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 25005615 ↗
• MalfunctionJan 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN BREAST AND ENDOCRINE SURGERY, IT SEEMED LIKE THE SUTURE DETACHED FROM THE SWAGE PART 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 23973913 ↗
• MalfunctionDec 24, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, FOR SXPP2B101, THE SUTURE DID NOT CATCH IN THE MIDDLE OF THE WOUND AND SLIPPED ALL THE WAY THROUGH. IT WAS NOT A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. 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 23888469 ↗
• MalfunctionDec 24, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, FOR SXPP2B101, THE SUTURE DID NOT CATCH IN THE MIDDLE OF THE WOUND AND SLIPPED ALL THE WAY THROUGH. IT WAS NOT A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. 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 23888460 ↗
• MalfunctionDec 24, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE DID NOT CATCH WELL AND COULD NOT BE TIGHTENED. 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 23887788 ↗
• MalfunctionDec 24, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE DID NOT CATCH WELL AND COULD NOT BE TIGHTENED. 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 23887762 ↗
• MalfunctionDec 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT WHEN THE DEVICE WAS USED DURING DERMAL SUTURING, THE NEEDLE AND THE SUTURE WERE DETACHED EASILY. THE NEEDLE WAS RETRIEVED AS IT IS. 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 23878550 ↗
• MalfunctionAug 27, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BREAST AND ENDOCRINE SURGERY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED IN A MAMMARY GLAND CASE. DURING THE PROCEDURE, IT CAME OUT EASILY AND THE BARB DID NOT GET CAUGHT. THE SUTURE THAT DID NOT GET CAUGHT WAS DISCARDED. THIS EVENT WAS FOUND BEFORE USE. 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 22903392 ↗
• MalfunctionAug 27, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BREAST AND ENDOCRINE SURGERY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED IN A MAMMARY GLAND CASE. DURING THE PROCEDURE, IT CAME OUT EASILY AND THE BARB DID NOT GET CAUGHT. THE SUTURE THAT DID NOT GET CAUGHT WAS DISCARDED. THIS EVENT WAS FOUND BEFORE USE. 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 22903384 ↗
• MalfunctionAug 14, 2025Material Separation; Material Separation

  IT WAS REPORTED PATIENT UNDERWENT AN UNKNOWN BREAST AND ENDOCRINE SURGERY ON (B)(6) 2025, AND BARBED SUTURE WAS USED ON THE SUBCUTANEOUS BREAST (DERMIS). DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EVEN THOUGH NO FORCE WAS APPLIED DURING STITCHING (SUBCUTANEOUS DERMAL SUTURE ON THE BREAST). IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809826 ↗
• MalfunctionAug 1, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NEEDLE AT THE TIP WAS BROKEN DURING SURGERY. THE BROKEN TIP HAS ALREADY BEEN FOUND. 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 22688266 ↗
• MalfunctionJul 22, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BREAST AND ENDOCRINE SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE BARB COULD NOT BE HOOKED. 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 22565597 ↗
• MalfunctionJul 22, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BREAST AND ENDOCRINE SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE BARB COULD NOT BE HOOKED. 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 22565572 ↗
• MalfunctionJul 22, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BREAST AND ENDOCRINE SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE BARB COULD NOT BE HOOKED. 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 22565561 ↗
• MalfunctionJul 15, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN BREAST AND ENDOCRINE SURGERY, THE BARBS WERE NOT CATCHING AS WELL AS USUAL. 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 22515813 ↗
• MalfunctionJul 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARTMAN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING HARTMAN SURGERY, THE NEEDLE WAS BROKEN DURING USE. THE DOCTOR DID NOT GRASP ESPECIALLY THE WEAK PARTS OF THE NEEDLE. THE BROKEN PIECES OF THE NEEDLE WERE FOUND THERE, AND IT WAS CONFIRMED THAT NO PIECES WERE LEFT INSIDE THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS USED ON THE DERMIS. 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 22478855 ↗
• MalfunctionJun 20, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BREAST AND ENDOCRINE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS NOT CAUGHT. THE PRODUCT WAS USED ON THE MAMMARY GLAND. 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 22302577 ↗
• MalfunctionJun 20, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BREAST AND ENDOCRINE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS NOT CAUGHT. THE PRODUCT WAS USED ON THE MAMMARY GLAND. 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 22302551 ↗