STRATAFIX SXPP2B102Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031465220), received between Jan 10, 2023 and Feb 24, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 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, THE NEEDLE AND THE SUTURE WERE DETACHED. IT IS STILL UNKNOWN WHETHER THE ISSUE OCCURRED BEFORE USE OR AFTER, SO THE DETAILS WOULD BE ADDED AS ADDITIONAL INFORMATION BECOMES AVAILABLE. 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 24432439 ↗
• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2024 AND BARBED SUTURE WAS USED FOR CONTINUOUS SUTURING. THIS WAS A CLINICAL EVALUATION CASE, AND THE SUTURE OF SAMPLE PRODUCT WAS BROKEN. THE LEFT SIDE FROM THE CENTER OF THE WOUND WAS STITCHED WITHOUT ANY PROBLEM, BUT THE SUTURE WAS BROKEN DURING STITCHING THE RIGHT SIDE. THE REINFORCE NODE WAS ADDED AND THE SUTURE WAS COMPLETED. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292436 ↗
• InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THA : TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. ABOUT THREE WEEKS POST-OP, IT WAS FOUND THAT THE SUTURE PROTRUDED FROM A DISTAL THA. THE PROTRUSION PART WAS EXCISED AND TREATMENT WAS DONE. AFTER THAT, THERE HAS BEEN NO PROBLEM. TWO WEEKS POSTOPERATIVELY, THE SUPERFICIAL COATING MATERIAL WAS REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 18395366 ↗
• MalfunctionJan 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE NEEDLE WAS BROKEN AT THE SWAGE PART DURING CONTINUOUS SUTURING. IT WAS BROKEN AT ABOUT THE LAST 1 ~ 2 STITCHES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16142801 ↗
• MalfunctionJan 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING WOUND CLOSURE ON THE SUBCUTANEOUS WITH CONTINUOUS SUTURING, AROUND AFTER THE SURGEON PUT THE SECOND STITCHES, THE NEEDLE WAS BROKEN AT THE SWAGE PART. THE BROKEN PIECE FELL INTO THE PATIENTS BODY. THE SURGEON SAID THAT HE GRASPED THE NEEDLE AROUND THE SWAGE PART DURING SUTURING. THE SALES REP EXPLAINED THE STRUCTURE OF THE SWAGE PART TO THE SURGEON. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132200 ↗