STRATAFIX SXMP2B416Recalls & reported problems
Ethicon, LLC · Stratafix (Spiral MONOCRYL Plus), Bidirectional · 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 10705031465114), received between Jul 25, 2025 and Jul 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (1 report).
1 other recall cover devices cleared under the same FDA submission (K192580); they may or may not involve this specific model.
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
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT ASSISTED PROSTATECTOMY PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT DURING A ROBOT ASSISTED PROSTATECTOMY, THE SURGEON FELT THAT THE SUTURE STRAND DID NOT ADEQUATELY HOLD THE TISSUE APPROXIMATED FOR THE UVA. THEY WERE UNABLE TO SEE THE BARBS UNDER THE MAGNIFICATION OF THE SCOPE. THE STRAND IN QUESTION IS NOT AVAILABLE FOR RETURN, BUT A STRAND FROM THE SAME BOX IS AVAILABLE FOR ANALYSIS. SURGICAL DELAY WAS UNKNOWN. NO PATIENT WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22621108 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192580. One submission often covers many models, so check the product and lot details in each record.
- Z-1533-2024 · Mar 8, 2024 · Open, ClassifiedSTRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft
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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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