Stratafix Spiral SXPL2B400Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2CT-1 -2- CL PPN 24X24 · Class 2 · Implant
All models of Stratafix Spiral (24)
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 10705031208209), received between Mar 7, 2023 and Apr 17, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Seroma1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2026 THAT ON (B)(6) 2025 A PATIENT HAD A SEROMA POST-OPERATIVELY WHICH WAS TREATED SUCCESSFULLY AND THEN IN (B)(6) 2026 A GRANULOMA FORMED WHICH WAS ALSO TREATED SUCCESSFULLY. NO ADDITIONAL MEDICAL INTERVENTION OR PATIENT INJURY REPORTED.
Patient problems: Seroma
MAUDE report 24916285 ↗MalfunctionMar 7, 2023Detachment of Device or Device Component
IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE THAT THEY OPENED THE FIRST PACKET AND SAID THE NEEDLE POPPED OFF AND THEY OPENED ANOTHER ONE AND THE NEEDLE POPPED OFF INSIDE THE PATIENT. THEY WERE ABLE TO RETRIEVED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT THAT REP IS AWARE OF. NO DEVICE IS AVAILABLE FOR RETURN. PATIENT IS FINE. PROCEDURE WAS HIATAL HERNIA AND NEEDLE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16500500 ↗
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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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