STRATAFIX SXMP2B412Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705031464285), received between Feb 29, 2024 and Mar 19, 2026 — classified as 8 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (17 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. Mar 8, 2024Open, Classified

   Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility

   Z-1533-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING PLASTIC SURGERY THE NEEDLE WAS COMING OFF WHILE THE SURGEON WAS SUTURING. THREE BOXES OF SUTURE WAS PUT ASIDE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641258 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPAEDIC PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING AN ORTHOPAEDIC PROCEDURE, THE SALES REP REPORTED THAT DURING WOUND CLOSURE THE NEEDLE TIP BROKE OFF AND WAS NOT RECOVERED; AN INTRAOPERATIVE X-RAY WAS PERFORMED DUE TO THE NATURE OF THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692804 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNSPECIFIED PROCEDURE, THE NEEDLE BROKE AFTER SURGERY, AND THE TIP WAS FOUND ON THE NEEDLE DRIVER AFTER THE SURGEON CUT THE SUTURE. MANAGEMENT WAS NOTIFIED. NO FOREIGN BODY WAS LEFT IN THE PATIENT. NO PATIENT CONSEQUENCES HAVE BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543668 ↗
• InjurySep 25, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE OR HIP PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE DID NOT ABSORB/BREAK DOWN WITHIN THE NORMAL TIME FRAME CAUSING NECROTIC TISSUE AND THE NEED TO BRING THE PATIENT BACK TO REOPERATE. THIS SPECIFIC INCIDENT WAS FROM A PATIENT WHO WAS INITIALLY OPERATED ON 3 MONTHS AGO AT A DIFFERENT FACILITY. PICTURES SHOW THAT MUCH OF THE SUTURE IS STILL INTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Necrosis

  MAUDE report 23150686 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22970941 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22969128 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22969100 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. SUTURE STILL THERE 4-6 WEEKS. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968757 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968466 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968391 ↗
• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN THEY WENT TO FLEX AND PUT THE TOPICAL SKIN ADHESIVE ON, THE SUTURE BROKE TOWARDS THE BOTTOM WHEN TRYING TO CLOSE AROUND THE TIBIA. NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20290359 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DISCOVERED A DEHISCENCE AND INCREASED BLEEDING AFTER THE PROCEDURE. THE PATIENT WENT IN NEXT DAY AND THE SURGEON CLEANED IT OUT AND THEN RE-CLOSED IT WITH NYLON SUTURES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 20267056 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. WHILE CLOSING THE RESIDENT NOTED THAT THERE WAS SOMETHING WRONG WITH THE DEVICE. THE SHARP TIP OF THE NEEDLE WAS MISSING, ABOUT LESS THAN ONE MILLIMETER. LOOKED LIKE PIECE BROKE OFF BUT WAS NOT FOUND DURING SURGERY. LIKE DEVICE WAS USED TO COMPLETE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809767 ↗
• MalfunctionApr 16, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SUTURE WAS DEGRADED AND FELL APART AS SOON AS ITS PACKAGING WAS OPENED ON AN UNKNOWN DATE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119881 ↗
• MalfunctionApr 16, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SUTURE WAS DEGRADED AND FELL APART AS SOON AS ITS PACKAGING WAS OPENED ON AN UNKNOWN DATE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119876 ↗
• MalfunctionApr 16, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SUTURE WAS DEGRADED AND FELL APART AS SOON AS ITS PACKAGING WAS OPENED ON AN UNKNOWN DATE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119869 ↗
• MalfunctionApr 16, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SUTURE WAS DEGRADED AND FELL APART AS SOON AS ITS PACKAGING WAS OPENED ON AN UNKNOWN DATE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119826 ↗
• MalfunctionApr 16, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SUTURE WAS DEGRADED AND FELL APART AS SOON AS ITS PACKAGING WAS OPENED ON AN UNKNOWN DATE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119809 ↗
• MalfunctionMar 21, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THREE SUTURE PACKETS WERE OPENED AND WHEN THE SUTURE WAS REMOVED IT SEEMED TO JUST FALL APART INTO MULTIPLE PIECES. THE SUTURE NEVER MADE IT TO THE SURGICAL FIELD BEFORE FALLING APART. STAPLES WERE USED FOR SKIN CLOSURE INSTEAD OF SUTURE AS THIS WAS THE ONLY BOX OF SUTURE THEY HAD ON HAND. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18955547 ↗
• MalfunctionMar 21, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THREE SUTURE PACKETS WERE OPENED AND WHEN THE SUTURE WAS REMOVED IT SEEMED TO JUST FALL APART INTO MULTIPLE PIECES. THE SUTURE NEVER MADE IT TO THE SURGICAL FIELD BEFORE FALLING APART. STAPLES WERE USED FOR SKIN CLOSURE INSTEAD OF SUTURE AS THIS WAS THE ONLY BOX OF SUTURE THEY HAD ON HAND. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18955545 ↗
• MalfunctionMar 21, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THREE SUTURE PACKETS WERE OPENED AND WHEN THE SUTURE WAS REMOVED IT SEEMED TO JUST FALL APART INTO MULTIPLE PIECES. THE SUTURE NEVER MADE IT TO THE SURGICAL FIELD BEFORE FALLING APART. STAPLES WERE USED FOR SKIN CLOSURE INSTEAD OF SUTURE AS THIS WAS THE ONLY BOX OF SUTURE THEY HAD ON HAND. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18955523 ↗
• MalfunctionMar 6, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND BARBED SUTURE WAS USED. THE SUTURE WAS BREAKING APART BEFORE IT COULD EVEN BE USED ON THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851548 ↗
• MalfunctionMar 6, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE IN 2024 AND BARBED SUTURE WAS USED. WHEN THE SUTURE WAS OPENED, IT "FELL APART". THE SUTURE MATERIAL CRACKED AND FELL INTO PIECES. THE SUTURE DID NOT FALL INTO THE PATIENT. THE CASE WAS COMPLETED WITH A DIFFERENT BOX OF SUTURE. NO PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851416 ↗
• MalfunctionMar 6, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE IN 2024 AND BARBED SUTURE WAS USED. WHEN THE SUTURE WAS OPENED, IT "FELL APART". THE SUTURE MATERIAL CRACKED AND FELL INTO PIECES. THE SUTURE DID NOT FALL INTO THE PATIENT. THE CASE WAS COMPLETED WITH A DIFFERENT BOX OF SUTURE. NO PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851356 ↗
• MalfunctionMar 6, 2024Material Discolored; Defective Component; Appropriate Device Problem Term/Code Not Available; Material Discolored; Defective Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6( 2024 AND BARBED SUTURE WAS USED. WHEN THEY WERE GETTING THE SUTURE OUT OF THE PACKAGING WITH THE NEEDLE HOLDER, THE PRODUCT APPEARED DRY ROTTED BUT IS WITHIN DATE AND WAS STORED PER IFU. THE SHARPS WERE DISCARDED. THE CASE WAS COMPLETED WITH A SUTURE FROM ANOTHER BOX. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851146 ↗