Stratafix Spiral SXMD2B406Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2FS-2 2-0 UNDYD MONODERM 14X14 · Class 2 · Implant
All models of Stratafix Spiral (24)
Data updated Oct 18, 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 10705031208063), received between Dec 17, 2021 and May 5, 2022 — 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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Laceration(s)1
- Wound Dehiscence1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO OUR DISTRIBUTOR THAT A PATIENT HAD TO BE TAKEN BACK TO THE THEATRE TO REPAIR A WOUND; DEHISCENCE POST-OPERATIVE AN UNDISCLOSED SURGERY.
Patient problems: Wound Dehiscence
MAUDE report 14290139 ↗InjuryDec 17, 2021Break
A PREGNANT WOMAN UNDERWENT CESAREAN SECTION WITH TRANSVERSE INCISION AT LOWER UTERINE SEGMENT UNDER SPINAL EPIDURAL ANESTHESIA ON (B)(6) 2021. THE OPERATION WENT SMOOTHLY. THE BARBED SUTURE WAS USED FOR SEWING THE SKIN LAYER. THE PATIENT WAS IN GOOD CONDITION ON THE SAME DAY. THE PATIENT HAD NO OTHER ABNORMAL REACTIONS. THE NEXT DAY ON (B)(6) 2021, PATROL FOUND BARBED SUTURE BROKE AND SKIN INCISIONS CRACKED, THE PATIENT WAS IMMEDIATELY PLACED IN THE OPERATING ROOM FOR LOCAL ANESTHESIA, THE SKIN INCISION WAS RESEWED AND THE PROCESS WAS SMOOTH, AND THE PATIENT DID NOT SEE OTHER ABNORMAL REACTIONS. THE BROKEN SUTURE WILL BE SENT BACK, AND THE HOSPITAL REQUIRES TO PROVIDE THE PRODUCT TEST REPORT AS SOON AS POSSIBLE.
Patient problems: Laceration(s)
MAUDE report 13026801 ↗
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
- 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