2-0 Uni Monoderm 20cm VLM-2005Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2-0 Uni Monoderm 20cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848782020485), received between Aug 24, 2021 and Jul 15, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Separation Problem” (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
- Separation Problem2
- Component Missing1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2024Separation Problem; Separation Problem
IT WAS REPORTED THAT A NEEDLE BROKE OFF THE SUTURE DURING SURGERY AND REQUIRED MEDICAL INTERVENTION TO REMOVE THE NEEDLE FROM THE PATIENT¿S CAVITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19746391 ↗MalfunctionJun 5, 2024Separation Problem; Separation Problem
IT WAS REPORTED THERE WAS A NEEDLE AND THREAD SEPARATION DURING A SURGICAL PROCEDURE. IN ONE CASE OF A TAPP PROCEDURE, THE NEEDLE SEPARATED AND GOT LOST IN THE BODY CAVITY, WHICH RESULTED IN A PROLONGED DURATION OF THE PROCEDURE. THIS IS ONE OF TWO DEVICES THAT WERE REPORTED. IT IS NOT CERTAIN WITH WHICH DEVICE THE EVENT OCCURRED. REFERENCE COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19470857 ↗MalfunctionAug 24, 2021Loose or Intermittent Connection; Component Missing
A QUILL NEEDLE BECAME LOOSE DURING THE PROCEDURE (RADICAL PROSTATECTOMY). THE NEEDLE DEVICE IS STILL MISSING. NOT FOUND IN THE PATIENT. IT IS NOT KNOWN IF THE DEVICE LOOSENED WHILE REMOVING THROUGH THE TROCAR. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12360179 ↗
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