STRATAFIX SXPP2B402Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031464773), received between Nov 12, 2024 and Dec 11, 2024 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2024 FOR A LEFT HIP SCAR REVISION WITH IRRIGATION AND DEBRIDEMENT, HEAD AND POLYETHYLENE LINER EXCHANGE. THE DEEP DERMAL AND SUPERFICIAL SUBCUTANEOUS LAYERS DEVELOPED A HYPERSENSITIVITY RESPONSE TO SUTURES WHICH CAUSED WOUND DEHISCENCE AND POTENTIAL DEEPER INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection; Wound Dehiscence

  MAUDE report 20907194 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A L TOTAL KNEE ARTHROPLASTY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DEEP DERMAL LAYER AND SUPERFICIAL LAYER DEVELOPED HYPERSENSITIVITY TO SUTURES. PROXIMAL PART OF THE INCISION WAS RED AND SWOLLEN. PATIENT WAS TREATED WITH ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 20907193 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. TAKEN BACK TO OPERATING ROOM (B)(6) 2024 FOR RIGHT HIP SCAR REVISION WITH IRRIGATION AND DEBRIDEMENT. THE DEEP DERMAL LAYER AND SUPERFICIAL SUBCUTANEOUS LAYER DEVELOPED A HYPERSENSITIVITY RESPONSE TO THE SUTURES AND CAUSED WOUND DEHISCENCE AND POTENTIAL DEEPER INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection; Wound Dehiscence

  MAUDE report 20906752 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. PATIENT REPORT DRAINAGE FROM HER INCISION ON (B)(6) 2024, DIAGNOSED WITH A SUTURE GRANULOMA TO THE PROXIMAL INCISION AND WOUND DEHISCENCE. THE DEEP DERMAL LAYER AND SUPERFICIAL SUBCUTANEOUS LAYER DEVELOPED A HYPERSENSITIVE RESPONSE TO THE SUTURES CAUSING WOUND DEHISCENCE AND POTENTIALLY DEEPER INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Granuloma; Hypersensitivity/Allergic reaction; Unspecified Infection; Wound Dehiscence

  MAUDE report 20906664 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. PATIENT WENT BACK TO OPERATING ROOM ON (B)(6) 2024 FOR A LEFT HIP INCISION WITH IRRIGATION AND DEBRIDEMENT, HEAD AND LINER EXCHANGE. THE DEEP DERMAL LAYER AND SUPERFICIAL SUBCUTANEOUS LAYER DEVELOPED A HYPERSENSITIVE RESPONSE TO THE SUTURES WHICH CAUSED WOUND DEHISCENCE AND POTENTIAL DEEPER INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection; Wound Dehiscence

  MAUDE report 20906663 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ROBOT ASSISTED TOTAL KNEE REPLACEMENT ON (B)(6) 2024 AND BARBED SUTURE WAS USED. PATIENT WAS TAKEN TO OPERATING ROOM (B)(6) 2024 FOR WOUND IRRIGATION/DEBRIDEMENT. THE DEEP DERMAL LAYER AND SUPERFICIAL SUBCUTANEOUS LAYER DEVELOPED A HYPERSENSITIVITY RESPONSE TO THE SUTURES CAUSING WOUND DEHISCENCE AND POTENTIAL DEEPER INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection; Wound Dehiscence

  MAUDE report 20906648 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT ROBOT ASSISTED TOTAL HIP ARTHROPLASTY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE PATIENT THEN UNDERWENT A RIGHT HIP INCISIONAL REVISION IRRIGATION/ DEBRIDEMENT ON (B)(6) 2024. PATIENT HAD AN ADDITIONAL RIGHT HIP IRRIGATION DEBRIDEMENT OF A SUPERFICIAL WOUND INFECTION ON (B)(6) 2024.THE DEEP DERMAL LAYER AND SUPERFICIAL SUBCUTANEOUS LAYER DEVELOPED A HYPERSENSITIVITY RESPONSE TO THE SUTURES CAUSING WOUND DEHISCENCE AND POTENTIAL DEEPER INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 20906560 ↗
• InjuryNov 12, 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 AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT HAS CREATED A GRANULOMA WHERE THEY HAVE TO BRING BACK THE PATIENT TO THE OR TO DEBRIS THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma

  MAUDE report 20666985 ↗
• MalfunctionNov 12, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE CUSTOMER IS REPORTING THAT THE SUTURE DOESN'T SEEM TO CATCH VERY EFFICIENTLY WHEN THEY TRY TO CLOSE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20665719 ↗