STRATAFIX SXMP1B412Recalls & reported problems
Ethicon, LLC · Knotless Tissue Control Device, Undyed Unidirectional (Antibacterial) Synthetic Absorbable Device · Class 2 · Implant
All models of STRATAFIX (181)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031236349), received between Jul 10, 2018 and Aug 5, 2022 — classified as 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 16, 2026.
Most reported problems
Device problems
- Break1
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THE SURGEON STATED THAT IT SNAPPED AT THE NEEDLE INSERTION POINT. A NEW SUTURE WAS OPENED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15174673 ↗MalfunctionJul 10, 2018Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT A PATIENT UNDERWENT A DAVINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2018 AND BARBED SUTURE WAS USED. THE SURGEON COMPLAINED THAT THE SUTURE BACKED OUT AND IS NOT A GOOD CROSS TO V-LOC 90 2-0. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7675461 ↗
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 16, 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