Stratafix Spiral SXPD2B405Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031207981), received between Sep 11, 2017 and Aug 18, 2025 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE KEPT DESWAGING FROM SUTURE. MINIMAL FORCE WAS USED, AND THE ISSUE OCCURRED WITH MULTIPLE SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827800 ↗
• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE KEPT DESWAGING FROM SUTURE. MINIMAL FORCE WAS USED, AND THE ISSUE OCCURRED WITH MULTIPLE SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827798 ↗
• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE KEPT DESWAGING FROM SUTURE. MINIMAL FORCE WAS USED, AND THE ISSUE OCCURRED WITH MULTIPLE SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827796 ↗
• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE KEPT DESWAGING FROM SUTURE. MINIMAL FORCE WAS USED, AND THE ISSUE OCCURRED WITH MULTIPLE SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827792 ↗
• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE KEPT DESWAGING FROM SUTURE. MINIMAL FORCE WAS USED, AND THE ISSUE OCCURRED WITH MULTIPLE SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827787 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT DURING POST OPERATION, THE PATIENT DEHISCED. THE SURGEON WASHED OUT THE PATIENT AND SUTURED TO RECLOSE THE INCISION. NO OTHER INTERVENTION REQUIRED.

  Patient problems: Wound Dehiscence

  MAUDE report 21689326 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT DURING POST OPERATION, THE PATIENT DEHISCED. THE SURGEON WASHED OUT THE PATIENT AND SUTURED TO RECLOSE THE INCISION. NO OTHER INTERVENTION REQUIRED.

  Patient problems: Wound Dehiscence

  MAUDE report 21689323 ↗
• InjuryMar 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED ON (B)(6) 2025 THAT THE DEVICE WAS NO LONGER HOLDING THE WOUND TOGETHER AND THE PATIENT HAD A NEGATIVE REACTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Wound Dehiscence

  MAUDE report 21635608 ↗
• InjuryMar 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED ON 25 FEBRUARY 2025 THAT THE DEVICE WAS NO LONGER HOLDING THE WOUND TOGETHER AND THE PATIENT HAD A NEGATIVE REACTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Wound Dehiscence

  MAUDE report 21634916 ↗
• InjurySep 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED THAT DR. (B)(6) HAD TO BRING PATIENT BACK THAT HE PERFORMED A TOTAL KNEE ON BECAUSE KNEE CAPSULE HAD SHIFTED TO THE SIDE. HE OPENED KNEE UP TO FIND STRATAFIX BROKEN IN THE MIDDLE. HE WENT TO FIX THE ISSUE PULLED ANOTHER STRATAFIX AND STARTING SEWING AND THE SUTURE BROKE. NO PATIENT HARM.

  Patient problems: Joint Dislocation

  MAUDE report 17821312 ↗
• MalfunctionJun 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING A LEFT TOTAL KNEE ARTHROPLASTY PROCEDURE THAT THE BEVEL EDGE OF ONE NEEDLE BROKE WHILE IN USE. NEEDLE WAS UNABLE TO BE FOUND EVEN AFTER AN X-RAY. SURGEON IS AWARE THAT THE FRAGMENT IS STILL INSIDE THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17184061 ↗
• InjuryJun 27, 2022Break

  IT WAS REPORTED BY THE ETHICON SALES REP THAT POST OP OF A TOTAL KNEE ARTHROSCOPY PATIENT RETURNED WITH A HEMATOMA. WHILE REPAIRING THE HEMATOMA THE SURGEON FOUND THAT THE SUTURE DID NOT HOLD. PATIENTS¿ STATUS WAS NOT PROVIDED TO THE SALES REP. FOUR STERILE SAMPLES WILL BE RETURNED.

  Patient problems: Hematoma

  MAUDE report 14834307 ↗
• InjurySep 11, 2017Component Missing

  PT HAD AN OXFORD UNICOMPARTMENTAL ARTHROPLASTY LEFT KNEE, PATELLOPLASTY. THE WOUND WAS CLOSED IN LAYERS AND A STERILE DRESSING WAS APPLIED. WHILE THE STAFF WERE GETTING THE PT READY FOR ROUTINE POST OP XRAYS, THE OPERATING ROOM SCRUB NURSE NOTICED THAT THE TIP OF 1 OF THE SUTURE NEEDLES TO BE MISSING. C-ARM XRAY SHOWED A QUESTIONABLE ABNORMAL METALLIC DENSITY. THE DRESSING WAS REMOVED, THE KNEE RE-PREPPED AND DRAPED, AND THE WOUND OPENED IN THE CENTRAL PORTION WHERE THE QUESTIONABLE METALLIC BODY WAS IDENTIFIED. A THOROUGH INSPECTION OF THE WOUND AND JOINT SPACE WAS CARRIED OUT. WOUND IRRIGATED WITH COPIOUS AMOUNTS OF SALINE. NO METALLIC DEBRIS WAS FOUND. A C-ARM XRAY WAS AGAIN USED TO IMAGE THE KNEE IN MULTIPLE PLANES, AND NO METALLIC FOREIGN BODY WAS FOUND. THE POLYETHYLENE BEARING WAS PLACED BACK INTO THE KNEE AND THE WOUND WAS ONCE AGAIN IRRIGATED AND CLOSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6854418 ↗