3-0 Uni Monoderm 60cm VLM-2004Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 3-0 Uni Monoderm 60cm · Class 2 · Implant
Data updated Oct 18, 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 00848782020461), received between Feb 5, 2025 and Feb 5, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Separation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2025Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem
IT WAS REPORTED TO THE VIGILANCE UNIT OF MEDICAL DEVICES OF THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES (AEMPS) BY A CUSTOMER THAT ON (B)(6) 2024 A SUTURE BROKE INTRA-OPERATIVELY AND THE NEEDLE TIP BECAME DULL DURING USE. NO MEDICAL INTERVENTION WAS REQUIRED AND NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313954 ↗MalfunctionFeb 5, 2025Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem
IT WAS REPORTED TO THE VIGILANCE UNIT OF MEDICAL DEVICES OF THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES (AEMPS) BY A CUSTOMER THAT ON (B)(6) 2024 A SUTURE BROKE INTRA-OPERATIVELY AND THE NEEDLE TIP BECAME DULL DURING USE. NO MEDICAL INTERVENTION WAS REQUIRED AND NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313834 ↗
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