Darby Dental Supply, LLC 640S-DARRecalls & reported problems
Darby Dental Supply, LLC · SUTURE SILK 3/8 NP-3 5/0 18" DARBY · 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 00889813003350), received between Apr 21, 2021 and Apr 21, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
DR. WAS PLACING SUTURES FOR A PERIODONTAL PROCEDURE. THE SUTURES WERE ON THE TABLE. AS THE DR. WENT TO GET ONE OF THE SUTURES IT WAS NOTICED THAT THE NEEDLE WAS NOT ATTACHED TO THE SUTURE. AS THE SUTURE COULD NOT BE IMMEDIATELY FOUND THE PATIENT WAS SENT TO THE EMERGENCY ROOM OUT OF AN ABUNDANCE OF CAUTION. THE NEEDLE WAS SUBSEQUENTLY FOUND ON THE FLOOR OF THE ROOM WHERE THE PROCEDURE WAS PERFORMED.
Patient problems: Insufficient Information
MAUDE report 11700359 ↗
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- Sofsilk S-304Covidien LP · SUTURE, NONABSORBABLE, SILK2 recalls2 reports
- Sofsilk S-316Covidien LP · SUTURE, NONABSORBABLE, SILK2 recalls2 reports
- Sofsilk S-187Covidien LP · SUTURE, NONABSORBABLE, SILK2 recalls1 report
- Sofsilk S-605Covidien LP · SUTURE, NONABSORBABLE, SILK2 recalls1 report
- Sofsilk S-246Covidien LP · SUTURE, NONABSORBABLE, SILK2 recalls0 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.
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