STRATAFIX SXMP1B451Recalls & reported problems
Ethicon, LLC · Knotless Tissue Control Device, Dyed 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031470088), received between Jun 4, 2025 and Jun 4, 2025 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Positioning Failure1
Patient problems
- Failure to Anastomose1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING A RADICAL PROSTATECTOMY PROCEDURE THAT AFTER SUTURING THE URETHRAL ANASTOMOSIS A LEAK TEST WAS DONE AND A LEAK WAS FOUND. SURGEON OVER SEWED THE ANASTOMOSIS WITH A DIFFERENT SUTURE CODE. ANOTHER LEAK TEST WAS DONE AND NO LEAKS WERE FOUND. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO DEVICE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Failure to Anastomose
MAUDE report 22144613 ↗
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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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