STRATAFIX SXPP2B400Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10705031464568), received between Aug 8, 2023 and Sep 21, 2026 — classified as 1 injury, 53 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (35 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 15, 2025Open, Classified

   Potential for barb non-engagement.

   Z-2605-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break

  It was reported that a patient underwent an unknown procedure in (b)(6) 2026 and barbed suture was used. In some cases, anchors are missing from the threads of the same item code with different lot numbers. Several foils were opened until one with an anchor was opened. The procedure was finished with this suture. There were no patient outcome. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838083 ↗
• MalfunctionSep 21, 2026Break

  It was reported that a patient underwent an unknown procedure in (b)(6) 2026 and barbed suture was used. In some cases, anchors are missing from the threads of the same item code with different lot numbers. Several foils were opened until one with an anchor was opened. The procedure was finished with this suture. There were no patient outcome. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838081 ↗
• MalfunctionSep 21, 2026Break

  It was reported that a patient underwent an unknown procedure in (b)(6) 2026 and barbed suture was used. In some cases, anchors are missing from the threads of the same item code with different lot numbers. Several foils were opened until one with an anchor was opened. The procedure was finished with this suture. There were no patient outcome. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838079 ↗
• MalfunctionSep 17, 2026Positioning Failure

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and barbed suture was used. The surgeon placed the first stitch and pulled the suture through the tissue. Due to the arrangement of the barbs on the suture, a noticeable resistance should normally be felt at the midpoint. However, the suture passed through the tissue without any difficulty and without catching. The surgeon then checked whether the barbs were present and commented that they were barely perceptible. A second suture was opened, and the barbs were compared again. According to the reporter, the product has deteriorated since the switch from SXPD2B400, and the barbs are noticeably less pronounced than before.No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802625 ↗
• MalfunctionApr 30, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, OPENED 3 PACKAGES OF THE SXPP2B400 SUTURE. THE BARBS WERE NOT GRASPING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050001 ↗
• MalfunctionApr 30, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, OPENED 3 PACKAGES OF THE SXPP2B400 SUTURE. THE BARBS WERE NOT GRASPING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048335 ↗
• MalfunctionApr 30, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, OPENED 3 PACKAGES OF THE SXPP2B400 SUTURE. THE BARBS WERE NOT GRASPING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048326 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. TWO SURGEONS WERE USING BARBED SUTURE AND THE SUTURE BROKE MULTIPLE TIMES IN THE CASES. UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24805008 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. TWO SURGEONS WERE USING BARBED SUTURE AND THE SUTURE BROKE MULTIPLE TIMES IN THE CASES. UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24804488 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT TWO SURGEONS WERE USING BARBED SUTURE AND THE SUTURE BROKE MULTIPLE TIMES IN THE CASES. UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756539 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT TWO SURGEONS WERE USING BARBED SUTURE AND THE SUTURE BROKE MULTIPLE TIMES IN THE CASES. UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746378 ↗
• MalfunctionMar 30, 2026Positioning Failure; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN KNEE SURGERY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SURGEON AND HIS COLLEAGUES PREVIOUSLY USED THE BARBED SUTURE FOR KNEE CAPSULE CLOSURE. WITH THE SWITCH FROM THE POLYMER PDO TO PDS PLUS, THE RETENTION OF THE BARBS HAS BEEN CRITICIZED. THE BARBED SUTURE CAN EASILY BE PULLED THROUGH THE TISSUE AGAINST THE ANCHORS, RESULTING IN A LACK OF CONFIDENCE IN THE SUTURE PLACEMENT. THE CAPSULE CLOSURE WAS PERFORMED WITH A BARBED SUTURE, IN WHICH THE CTX NEEDLE OFTEN BENDS AT THE PROXIMAL START OF THE SUTURE. THEREFORE, THEY SWITCHED BACK TO THE BIDIRECTIONAL BARBED SUTURE. SURGERY WAS DELAYED 10 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729898 ↗
• MalfunctionMar 30, 2026Positioning Failure; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN KNEE SURGERY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SURGEON AND HIS COLLEAGUES PREVIOUSLY USED THE BARBED SUTURE FOR KNEE CAPSULE CLOSURE. WITH THE SWITCH FROM THE POLYMER PDO TO PDS PLUS, THE RETENTION OF THE BARBS HAS BEEN CRITICIZED. THE BARBED SUTURE CAN EASILY BE PULLED THROUGH THE TISSUE AGAINST THE ANCHORS, RESULTING IN A LACK OF CONFIDENCE IN THE SUTURE PLACEMENT. THE CAPSULE CLOSURE WAS PERFORMED WITH A BARBED SUTURE, IN WHICH THE CTX NEEDLE OFTEN BENDS AT THE PROXIMAL START OF THE SUTURE. THEREFORE, THEY SWITCHED BACK TO THE BIDIRECTIONAL BARBED SUTURE. SURGERY WAS DELAYED 10 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728915 ↗
• MalfunctionDec 19, 2025Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ORTHOPEDIC PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE PARTICULAR PIECE OF SUTURE HAS AN UNUSUALLY SMOOTH SURFACE, WITH THE BARD NOT DEEP ENOUGH TO PROVIDE PROPER HOLDING STRENGTH COMPARED THE OTHER SUTURES. UPON OPENING THE PACKAGING, HE IMMEDIATELY NOTICED THE DIFFERENCE BY TOUCH, AS THE SUTURE FELT MUCH SMOOTHER THAN USUAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851649 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE DOCTOR WAS USING A BARBED SUTURE AND THE SUTURE SUDDENLY BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849167 ↗
• MalfunctionDec 4, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. OR NURSE INFORMED ME THAT SXPP2B400 LOT 104UC3 BARBS ON THE SUTURE DO NOT PROVIDE THE SAME TRACTION AS THE PREVIOUS SUTURE DID SXPD2B400. THE SUTURE BEGAN TO SLIP AS WE WERE DOING THE DIASTASIS REPAIR. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715222 ↗
• MalfunctionOct 15, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, DR WAS USING SXPP2B400 AT MOUNT ELIZABETH NOVENA HOSPITAL, AND FELT THAT THE SUTURE DOES NOT CATCH PROPERLY AT THE TRANSITION POINT, AND THOUGHT THE BARBS OF SXPP2B400 DO NOT CATCH AS WELL AS THE BARBS OF SXPD2B400. HE WAS FRUSTRATED WITH THE SUTURE AND SWITCHED TO VICRYL 1 INSTEAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303722 ↗
• MalfunctionSep 3, 2025Defective Component; Appropriate Device Problem Term/Code Not Available; Defective Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SURGEON COULD NOT FEEL THE BARBS ALONG THE SUTURE LINE, BARBS NOT PROMINENT AT ALL. THERE WAS NO DELAY DUE TO THE EVENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953959 ↗
• MalfunctionSep 3, 2025Defective Component; Appropriate Device Problem Term/Code Not Available; Defective Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. BARBS COULD NOT BE FELT BY SURGEON AS HE RAN HIS FINGERS THROUGH THE SUTURE LINE. NOT AS PROMINENT AS HOW IT WAS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953282 ↗
• MalfunctionAug 14, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBED SUTURE HAD NO BARBS AND THEREFORE, NOT USED ON THE PATIENT. A SECOND BARBED SUTURE WAS OPENED AND THAT SUTURE HAD BARBS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. UPON EVALUATION, THE RETURNED DEVICES DID NOT MEET THE SPECIFIED REQUIREMENTS FOR THE BARB MEASUREMENTS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805120 ↗
• MalfunctionAug 14, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE CAME WITH NO BARBS STRAIGHT OUT FROM PACKAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED. UPON EVALUATION, THE RETURNED DEVICES DID NOT MEET THE SPECIFIED REQUIREMENTS FOR THE BARB MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803098 ↗
• MalfunctionJul 25, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WAS ALERTED BY CLINIC NURSE THAT DR EXPERIENCED 2X FAULTY SXPP2B400 WHERE BARBED SUTURE WAS TOTALLY SMOOTH AND UNABLE TO CATCH ONTO TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610523 ↗
• MalfunctionJul 25, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WAS ALERTED BY CLINIC NURSE THAT DR EXPERIENCED 2X FAULTY SXPP2B400 WHERE BARBED SUTURE WAS TOTALLY SMOOTH AND UNABLE TO CATCH ONTO TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610495 ↗
• MalfunctionJun 25, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE BARBS ARE NOT PRONOUNCED AS THEY NORMALLY ARE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DEVICES WERE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328997 ↗
• MalfunctionJun 25, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE BARBS ARE NOT PRONOUNCED AS THEY NORMALLY ARE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DEVICES WERE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328996 ↗