Stratafix Spiral SXMD1B100Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · PS-1 2-0 MONODERM 30CM · Class 2 · Implant
All models of Stratafix Spiral (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031228047), received between Jul 24, 2024 and Jul 24, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Mar 24, 2022Open, Classified
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Z-1053-2022 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
OUR DISTRIBUTOR REPORTED THAT A SUTURE DEVICE WAS USED DURING SURGERY. SEVERAL DAYS AFTER THE SURGERY, THE WOUND WAS FOUND WITH SUTURE EXTRUSION.
Patient problems: Foreign Body In Patient
MAUDE report 19820836 ↗
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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 · each recall links to the FDA recall notice
- 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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