Stratafix Spiral SXMD1B403Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · RB-1 2-0 MONODERM 20CM · Class 2 · Implant
All models of Stratafix Spiral (24)
Data updated Oct 18, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031228054), received between Mar 17, 2022 and Aug 11, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Recalls naming this device
- Mar 24, 2022Class IIOpen, 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
- Break1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Wound Dehiscence1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025 THAT POST-OPERATIVELY THE SURGICAL INCISION RUPTURED AND CAUSED BLEEDING. AN ADDITIONAL OPERATION WAS COMPLETED AND THE PATIENT IS REPORTEDLY STABLE. NO OTHER INJURIES REPORTED.
Patient problems: Wound Dehiscence
MAUDE report 22776426 ↗MalfunctionMar 17, 2022Nonstandard Device
WRONG NEEDLE TYPE. IT WAS REPORTED THAT THE NEEDLE TYPE WAS FOUND TO BE INCONSISTENT WITH THE ACTUAL SPECIFICATION. IT WAS A CUTTING NEEDLE RATHER THAN A TAPER POINT NEEDLE WHEN THE PACKAGE WAS OPENED FOR AN UNKNOWN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT OF PATIENT INJURY. NOT USED IN THE PROCEDURE. ANOTHER DEVICE WAS READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13801309 ↗
Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices
- Coated VICRYL VCP433HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death1,093 reports
- Polysorb CL-915Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID503 reports
- Coated VICRYL VCP493HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page