Stratafix Spiral SXPD1B400Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · CT-1 0 PDO 20CM · Class 2 · Implant
All models of Stratafix Spiral (24)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031227958), received between Jun 1, 2022 and Jun 30, 2023 — classified as 1 injury, 2 malfunctions.
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 18, 2026.
Most reported problems
Device problems
- Break1
- Device Fell1
- Difficult or Delayed Positioning1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Retroperitoneal Hemorrhage1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning
IT WAS REPORTED BY THE HEALTH AUTHORITY TO OUR DISTRIBUTOR THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW VAGINAL STUMP. RESULTING IN RESIDUAL SUTURES IN THE PATIENT'S BODY. THE RUPTURED SUTURES WERE REMOVED, CHANGED ANOTHER ONE TO COMPLETE THE SURGERY, INCREASING TISSUE OOZING AND PROLONGING THE SURGICAL TIME.
Patient problems: Retroperitoneal Hemorrhage
MAUDE report 17235152 ↗MalfunctionSep 27, 2022Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER LIKE DEVICE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15490886 ↗MalfunctionJun 1, 2022Break; Device Fell
IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE TIP BROKE DURING SEWING THE CERVICAL STUMP AND THE NEEDLE FELL INTO PATIENT. THE SURGERY TIME PROLONGED MORE THAN HALF HOUR TO LOOK FOR AND RETRIEVED BROKEN NEEDLE FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14569423 ↗
Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices
- STRATAFIX SXPP1A405Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE617 reports
- STRATAFIX SXPP1A400Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE485 reports
- STRATAFIX SXPP1A401Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE446 reports
- STRATAFIX SXPP1A301Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE443 reports
- STRATAFIX SXPP2B405Ethicon, LLC · Suture, surgical, absorbable, polydioxanone406 reports
- STRATAFIX SXPP1A406Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE339 reports
- STRATAFIX SXPP1A404Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death319 reports
- STRATAFIX SXPP1B420Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death229 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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