STRATAFIX SXPP2B405Recalls & reported problems

Summary

The FDA's MAUDE database contains 406 adverse event reports that list this exact device (DI 10705031464544), received between Mar 6, 2023 and Sep 24, 2026 — classified as 4 injuries, 402 malfunctions.

The most frequently reported specific device problem is “Material Separation” (300 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 406 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889863 ↗
• MalfunctionSep 24, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889862 ↗
• MalfunctionJun 12, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WE CONTINUE TO RECEIVE COMPLAINTS FROM OUR ORTHOPEDICS SFX USERS REGARDING THE PERFORMANCE OF BARBS WHEN SWITCHING TO STRATAFIX SIZE 1 SABRATOOTH. THEY ARE HESITANT TO USE STRATAFIX SABRATOOTH BECAUSE THEY DOUBT THAT IT USES THE SAME TECHNOLOGY AS THE PREVIOUS VERSION. ADDITIONALLY, THEY HAVE OBSERVED THAT THE SABRATOOTH STRATAFIX APPEARS LOOSE AND DOES NOT FIX AS SECURELY AS THE PREVIOUS VERSION. WE CONDUCTED AN INTERNAL COMPARISON BETWEEN ANGIOTECH SFX AND SABRATOOTH SFX. IT SEEMS THAT THE BARB CONTACT IN THE ANGIOTECH VERSION PROVIDES A STRONGER FIXATION. WHEN TAKING PHOTOS, THE BARB OF THE ANGIOTECH PRODUCT APPEARS CLEARER AND MORE DEFINED THAN THAT OF SABRATOOTH SFX. GIVEN THIS SITUATION, SINCE OUR CUSTOMERS ARE RELUCTANT TO SWITCH TO SFX SABRATOOTH AND DO NOT WANT TO CHANGE TECHNIQUES TO UNIDIRECTIONAL SYMMETRIC STRATAFIX, WE PLAN TO CONTINUE SELLING ANGIOTECH STRATAFIX UNTIL WE CAN ADDRESS THESE CONCERNS RAISED BY OUR SURGEONS. AS WE KNOW, SABRATOOTH STRATAFIX IS IN CODE Z, AND YOUR DIRECTION HAS BEEN TO ENCOURAGE COUNTRIES TO TRANSITION TO CODES A, B, OR C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485354 ↗
• MalfunctionJun 3, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING TOTAL JOINT PROCEDURE THE NEEDLES WERE OBSERVED TO DETACH REPEATEDLY FROM THE SUTURES. A DIFFERENT LOT NUMBER WAS SUBSEQUENTLY OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383174 ↗
• MalfunctionMay 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT TO SALES REP THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE NEEDLES POPPED OFF WHILST SUTURING AND THIS HAPPENED ON THREE DIFFERENT PATIENTS. NO PATIENT CONSEQUENCES REPORTED. DEVICES WILL BE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256550 ↗
• MalfunctionMay 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT TO SALES REP THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE NEEDLES POPPED OFF WHILST SUTURING AND THIS HAPPENED ON THREE DIFFERENT PATIENTS. NO PATIENT CONSEQUENCES REPORTED. DEVICES WILL BE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256456 ↗
• MalfunctionMay 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT TO SALES REP THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE NEEDLES POPPED OFF WHILST SUTURING AND THIS HAPPENED ON THREE DIFFERENT PATIENTS. NO PATIENT CONSEQUENCES REPORTED. DEVICES WILL BE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256452 ↗
• MalfunctionMay 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT TO SALES REP THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE NEEDLES POPPED OFF WHILST SUTURING AND THIS HAPPENED ON THREE DIFFERENT PATIENTS. NO PATIENT CONSEQUENCES REPORTED. DEVICES WILL BE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256120 ↗
• MalfunctionMay 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT TO SALES REP THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE NEEDLES POPPED OFF WHILST SUTURING AND THIS HAPPENED ON THREE DIFFERENT PATIENTS. NO PATIENT CONSEQUENCES REPORTED. DEVICES WILL BE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256117 ↗
• 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 25240740 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THEY AN INCREASE IN SUTURES BREAKING RECENTLY. THERE ARE NO INJURIES OR ADVERSE EVENT REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25188890 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THEY AN INCREASE IN SUTURES BREAKING RECENTLY. THERE ARE NO INJURIES OR ADVERSE EVENT REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25188712 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THEY AN INCREASE IN SUTURES BREAKING RECENTLY. THERE ARE NO INJURIES OR ADVERSE EVENT REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25188601 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THEY AN INCREASE IN SUTURES BREAKING RECENTLY. THERE ARE NO INJURIES OR ADVERSE EVENT REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25188459 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY AN INCREASE IN SUTURES BREAKING RECENTLY. THERE ARE NO INJURIES OR ADVERSE EVENT REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25188347 ↗
• MalfunctionMay 13, 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 THE SALES REP THAT AS THE ORTHOPEDIC SURGEON WAS CLOSING IN HIS TOTAL JOINT CASES, "THE NEEDLES HAS BEEN POPPING OFF THE SUTURE ALL DAY." THE MATERIALS COORDINATOR SHARED, "THIS HAS RESULTED IN THE CIRCULATOR NEEDING TO OPEN FREE NEEDLES FOR HIM TO PROCEED CLOSING." THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164482 ↗
• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT AS THE ORTHOPEDIC SURGEON WAS CLOSING IN HIS TOTAL JOINT CASES, "THE NEEDLES HAS BEEN POPPING OFF THE SUTURE ALL DAY." THE MATERIALS COORDINATOR SHARED, "THIS HAS RESULTED IN THE CIRCULATOR NEEDING TO OPEN FREE NEEDLES FOR HIM TO PROCEED CLOSING." THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164479 ↗
• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT AS THE ORTHOPEDIC SURGEON WAS CLOSING IN HIS TOTAL JOINT CASES, "THE NEEDLES HAS BEEN POPPING OFF THE SUTURE ALL DAY." THE MATERIALS COORDINATOR SHARED, "THIS HAS RESULTED IN THE CIRCULATOR NEEDING TO OPEN FREE NEEDLES FOR HIM TO PROCEED CLOSING." THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164452 ↗
• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT AS THE ORTHOPEDIC SURGEON WAS CLOSING IN HIS TOTAL JOINT CASES, "THE NEEDLES HAS BEEN POPPING OFF THE SUTURE ALL DAY." THE MATERIALS COORDINATOR SHARED, "THIS HAS RESULTED IN THE CIRCULATOR NEEDING TO OPEN FREE NEEDLES FOR HIM TO PROCEED CLOSING." THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164443 ↗
• MalfunctionMay 1, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A TOTAL KNEE ARTHROSCOPY PROCEDURE, THE NEEDLE WAS POPPING OFF AS IT WAS PASSED THROUGH TISSUE. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE RETURNING.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058706 ↗
• MalfunctionApr 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY AND TOTAL KNEE ARTHROPLASTY PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING TOTAL HIP ARTHROPLASTY AND TOTAL KNEE ARTHROPLASTY PROCEDURES, THE NEEDLE DETACHED FROM THE SUTURE WHEN IT WAS PULLED OUT. THE TEAM TRIED FOUR DIFFERENT UNITS AND EXPERIENCED THE SAME ISSUE. A DIFFERENT LOT NUMBER WAS THEN PROVIDED TO THE PHYSICIANS, AND NO ISSUES WERE ENCOUNTERED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031674 ↗
• MalfunctionApr 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEIR TEAM JUST REPORTED 3 EACH OF SXPP2B405 WHERE THE NEEDLE WAS POPPING OFF DURING SURGERY. THEY WENT AHEAD AND PULLED THE REST OF THE BOX JUST IN CASE. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019061 ↗
• MalfunctionApr 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEIR TEAM JUST REPORTED 3 EACH OF SXPP2B405 WHERE THE NEEDLE WAS POPPING OFF DURING SURGERY. THEY WENT AHEAD AND PULLED THE REST OF THE BOX JUST IN CASE. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25018963 ↗
• MalfunctionApr 27, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED BY THE SURGEON TO THE SALES REP THAT DURING TOTAL KNEE PROCEDURES, THE NEEDLE BROKE OFF AT THE SWEDGE. THIS OCCURRED ON TWO DIFFERENT PATIENTS ON THE SAME DAY. NO PATIENT HARM WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001825 ↗
• MalfunctionApr 27, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING TOTAL KNEE PROCEDURES, THE NEEDLE BROKE OFF AT THE WEDGE. THIS OCCURRED ON TWO DIFFERENT PATIENTS ON THE SAME DAY. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001636 ↗