STRATAFIX SXPP2B100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031465190), received between Jan 27, 2023 and Mar 6, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. DURING DERMAL CLOSURE, THE NEEDLE TIP BROKE. THE HOSPITAL DETERMINED THAT BASED ON X-RAY RESULTS, NO FOREIGN MATTER LEFT IN THE PATIENT. THE WOUND WAS RE-CLOSED WITH A DIFFERENT SUTURE. AFTER THAT, NO ADDITIONAL TREATMENT IS PLANNED. THE PATIENT¿S CONDITION IS NO PARTICULAR DIFFERENCES COMPARABLE TO OTHER CASES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536147 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS BROKEN DURING OPERATION. THIS EVENT OCCURRED WHEN THE DOCTOR TRIED TO SUTURE THE WOUND AS USUAL AND THE SUTURE WAS PULLED, BUT THE SUTURE AT THE MIDDLE PART SUDDENLY WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. AFFILIATE REFERENCE NUMBER: (B)(4). NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636640 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USE ON THE DERMIS. POST-OP, THE PATIENT EXPERIENCED A SURFACE SSI AFTER THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 20236989 ↗
• MalfunctionSep 3, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, DURING CONTINUOUS SUTURING, THE SPIRAL BARB IS WEAK. ESPECIALLY, THE HALF OF THE BARB SEEMS TO HAVE A WEAK IMPRESSION. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 20129235 ↗
• MalfunctionSep 3, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, DURING CONTINUOUS SUTURING, THE SPIRAL BARB IS WEAK. ESPECIALLY, THE HALF OF THE BARB SEEMS TO HAVE A WEAK IMPRESSION. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 20129180 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA: TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED ON THE DERMIS. THE PATIENT HAD THIN SKIN. POSTOPERATIVELY, PARTIAL NECROSIS OCCURRED. THE WOUND WITH THE CLINICAL SAMPLE WAS PARTIALLY NECROTIC. IT WAS REPORTED THAT THE SUTURE MAY HAVE BEEN PULLED TOO HARD, RESULTING IN TISSUE CONTUSION. ALSO, THERE MAY HAVE BEEN A GAP OR MISALIGNMENT BETWEEN THE WOUNDS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Necrosis

  MAUDE report 18668641 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (B)(6) 2023 AND BARBED SUTURE WAS USED. WHILE USING THE PRODUCT IN A DERMAL SUTURE, THE NEEDLE TIP FELL DURING SUTURE, BUT FELL INTO A BODY PART WHERE IT COULD BE REMOVED IMMEDIATELY. THE NEEDLE TIP WAS RETRIEVED. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016580 ↗
• MalfunctionJan 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA: TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURING ON DERMIS. THE NEEDLE DID NOT FALL BECAUSE IT WAS GRASPED. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16258367 ↗