PDO, Violet, 3-0, 15cm, Taper Point, 1/2 Circle, 26mm, Uni-directional VLP-2045Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · PDO, Violet, 3-0, 15cm, Taper Point, 1/2 Circle, 26mm, Uni-directional · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848782000401), received between Oct 6, 2023 and Oct 6, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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.
Reports received per month
Most reported problems
Device problems
- Material Separation1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 6, 2023Material Separation; Material Separation
NEEDLE DETACHED DURING A LAP HERNIA PROCEDURE. THE NEEDLE HAD TO BE SEARCHED FOR INSIDE THE BODY. NO DETAILS WERE DISCLOSED REGARDING DELAY, INJURY OR TYPE OF INTERVENTION. ADDITIONAL DETAILS WERE REQUESTED. NO DETAILS RECEIVED TO DATE. NO SAMPLES RECEIVED TO DATE.
Patient problems: Needle Stick/Puncture
MAUDE report 17889425 ↗
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- STRATAFIX SXPP2B405Ethicon, LLC · Suture, surgical, absorbable, polydioxanone406 reports
- STRATAFIX SXPP1A406Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE339 reports
- STRATAFIX SXPP1A404Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death319 reports
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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.
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