Stratafix Spiral SXMD2B409Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2FS-2 3-0 UNDYD MONODERM 30X30 · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031207769), received between Jan 14, 2025 and Sep 11, 2025 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Neck Pain1
- No Clinical Signs, Symptoms or Conditions1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025 DURING USE A NEEDLE BROKE. THE PIECES WERE REMOVED AND OEDEMA AND CERVICAL PAIN WERE REPORTED AS SECONDARY EFFECTS. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Neck Pain; Swelling/ Edema
MAUDE report 23031873 ↗InjuryJan 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE NEEDLE DETACHED FROM THE SUTURE AND FELL INTO THE PATIENT. X-RAYS WERE USED TO RETRIEVE THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21148273 ↗
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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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