STRATAFIX SXMP1B110Recalls & reported problems
Ethicon, LLC · Knotless Tissue Control Device, Undyed Unidirectional (Antibacterial) Synthetic Absorbable Device · Class 2 · Implant
All models of STRATAFIX (181)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031236639), received between Mar 20, 2018 and Sep 15, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient1
- Not Applicable1
- Swelling1
- Wound Dehiscence1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2020Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNICOMPARTMENTAL KNEE ARTHROPLASTY ON (B)(6) 2020 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF SUTURE WHILE CLOSING SUBCUTICULAR LAYER. THE SUTURE ITSELF DETACHED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10534343 ↗InjuryMar 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A PATIENT UNDERWENT TOTAL KNEE PROCEDURE ON (B)(6) 2018 AND BARBED SUTURE WAS USED ON SUBCUTICULAR TISSUE. THE MORNING OF (B)(6) 2018 THE PATIENT EXPERIENCED WOUND REOPENING FROM THE PROXIMAL END TO APPROXIMATELY THE MIDDLE OF THE 11- INCH INCISION. THE WOUND WAS RECLOSED USING TOPICAL ADHESIVE. THE SURGEON OPINED THAT THE PATIENT HIGHER BMI AND SIGNIFICANT SWELLING AFTER SURGERY MAY HAVE CONTRIBUTED TO THE DEHISCENCE. THE PATIENT IS CURRENTLY DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Not Applicable; Swelling; Wound Dehiscence
MAUDE report 7355289 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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