Stratafix Spiral SXPD2B426Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031207936), received between Sep 30, 2021 and Jan 7, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (7 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.

• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT POST-OPERATIVELY, THE PATIENT EXPERIENCED EXUDATION OF THE WOUND. THE SURGEON RE-SUTURED TO CLOSE THE INCISION. NO OTHER INTERVENTION REQUIRED. IT DOES NOT APPEAR THAT THE ADVERSE REACTION WAS RELATED TO ANY SUTURE DEFECT OR MALFUNCTION.

  Patient problems: Fluid Discharge

  MAUDE report 23992163 ↗
• InjuryOct 21, 2021Material Protrusion/Extrusion

  THE PATIENT HAD C-SECTION SURGERY IN (B)(6) 2021 DUE TO SCARRED UTERUS. AND WAS DISCHARGED 3 DAYS AFTER OPERATION. (B)(6), THE PATIENT CAME TO THE HOSPITAL FOR REEXAMINATION AND COMPLAINED OF POOR WOUND HEALING, UNABSORBED SUTURE, AND THE APPEARANCE OF THE SUTURE CAME OUT FROM SKIN, AND THE HOSPITAL REMOVED THE UNABSORBED SUTURE AND ASKED FOR CLARIFICATION FROM COMPANY. CLINICAL FEEDBACK THAT IT MAYBE RELATED TO SUTURE ABSORPTION DEGRADATION TOO SLOW AND FOREIGN BODY REACTION.

  Patient problems: Impaired Healing

  MAUDE report 12672752 ↗
• InjuryOct 1, 2021Material Protrusion/Extrusion

  POST-OP INFECTION. THIS CASE IS FROM HEALTH AUTHORITY. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A JOHNSON & JOHNSON SURGICAL KNOT- FREE SUTURE FOR THE CAESAREAN SECTION INCISION SUTURE. A MONTH PLUS LATER, IT WAS FOUND THAT THE WOUND SEWED HAD BEEN INFECTED. THE THREAD TIP OF THE SUTURE HAD BEEN EXTRUDED OUT OF THE ABDOMINAL INCISION, WHERE ALSO HAD AN ULCER. THE INCISION WAS CURRENTLY HEALED AFTER CUTTING OFF THE EXTRUDED THREAD TIP. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Ulcer; Unspecified Infection

  MAUDE report 12561865 ↗
• InjuryOct 1, 2021Material Protrusion/Extrusion

  POST-OP INFECTION. THIS CASE IS FROM HEALTH AUTHORITY. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A JOHNSON & JOHNSON SURGICAL KNOT- FREE SUTURE FOR THE CAESAREAN SECTION INCISION SUTURE. THREE MONTHS PLUS LATER, IT WAS FOUND THAT THE WOUND SEWED HAD BEEN INFECTED. THE THREAD TIP OF THE SUTURE HAD BEEN EXTRUDED OUT OF THE ABDOMINAL INCISION, WHERE ALSO HAD AN ULCER. THE INCISION WAS CURRENTLY HEALED AFTER CUTTING OFF THE EXTRUDED THREAD TIP. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Ulcer; Unspecified Infection

  MAUDE report 12561809 ↗
• InjuryOct 1, 2021Material Protrusion/Extrusion

  POST-OP INFECTION. THIS CASE IS FROM HEALTH AUTHORITY. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A JOHNSON & JOHNSON SURGICAL KNOT- FREE SUTURE FOR THE CAESAREAN SECTION INCISION SUTURE. ABOUT TWO MONTHS PLUS LATER, IT WAS FOUND THAT THE WOUND SEWED HAD BEEN INFECTED. THE THREAD TIP OF THE SUTURE HAD BEEN EXTRUDED OUT OF THE ABDOMINAL INCISION, WHERE ALSO HAD AN ULCER. THE INCISION WAS CURRENTLY HEALED AFTER CUTTING OFF THE EXTRUDED THREAD TIP. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Ulcer; Unspecified Infection

  MAUDE report 12561774 ↗
• InjuryOct 1, 2021Material Protrusion/Extrusion

  POST-OP INFECTION. THIS CASE IS FROM HEALTH AUTHORITY. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A JOHNSON & JOHNSON SURGICAL KNOT- FREE SUTURE FOR THE CAESAREAN SECTION INCISION SUTURE. ABOUT TWO MONTHS PLUS LATER, IT WAS FOUND THAT THE WOUND SEWED HAD BEEN INFECTED. THE THREAD TIP OF THE SUTURE HAD BEEN EXTRUDED OUT OF THE ABDOMINAL INCISION, WHERE ALSO HAD AN ULCER. THE INCISION WAS CURRENTLY HEALED AFTER CUTTING

  Patient problems: Ulcer; Unspecified Infection

  MAUDE report 12561748 ↗
• InjuryOct 1, 2021Material Protrusion/Extrusion

  POST-OP INFECTION. THIS CASE IS FROM HEALTH AUTHORITY. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A JOHNSON & JOHNSON SURGICAL KNOT- FREE SUTURE FOR THE CAESAREAN SECTION INCISION SUTURE. ABOUT FOUR MONTHS PLUS LATER, IT WAS FOUND THAT THE WOUND SEWED HAD BEEN INFECTED. THE THREAD TIP OF THE SUTURE HAD BEEN EXTRUDED OUT OF THE ABDOMINAL INCISION, WHERE ALSO HAD AN ULCER. THE INCISION WAS CURRENTLY HEALED AFTER CUTTING OFF THE EXTRUDED THREAD TIP. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Ulcer; Unspecified Infection

  MAUDE report 12561682 ↗
• InjurySep 30, 2021Material Protrusion/Extrusion

  POST-OP INFECTION. THIS CASE IS FROM HEALTH AUTHORITY. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A JOHNSON & JOHNSON SURGICAL KNOT- FREE SUTURE FOR THE CAESAREAN SECTION INCISION SUTURE. ABOUT A MONTH PLUS LATER, IT WAS FOUND THAT THE WOUND SEWED HAD BEEN INFECTED. THE THREAD TIP OF THE SUTURE HAD BEEN EXTRUDED OUT OF THE ABDOMINAL INCISION, WHERE ALSO HAD AN ULCER. THE INCISION WAS CURRENTLY HEALED AFTER CUTTING OFF THE EXTRUDED THREAD TIP. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 12558783 ↗