Hu-Friedy Mfg. Co., LLC PSN698NRecalls & reported problems
Hu-Friedy Mfg. CO., LLC · 5-0 BLACK NYLON SUTURE 18", C-3 NEEDLE 13MM, 3/8 CIRCLE PREMIUM REVERSE CUT · 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 10889950001650), received between Nov 7, 2018 and Nov 7, 2018 — 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.
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2018Material Separation
IT WAS REPORTED THE NEEDLE WAS SEPARATING FROM NYLON SUTURE DURING ENDODONTIC PROCEDURES. AT THE BEGINNING OF SUTURING PROCESS, THE THREAD WOULD COME APART FROM NEEDLE FORCING THE DOCTOR TO GRAB A NEW SUTURE. THE EVENT OCCURRED WITH 3 DIFFERENT PATIENTS UTILIZING SUTURES FROM LOT# 171115-53. ALL PIECES WERE RETRIEVED AND NONE OF THE PATIENTS WERE HARMED. NO MEDICAL INTERVENTION WAS NECESSARY; NO MEDICAL TREATMENT OR FOLLOW-UP WAS REQUIRED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8047093 ↗
Other Suture, Nonabsorbable, Synthetic, Polyamide devices
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- ETHILON 1696GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE118 reports
- Monosof SN-3695Covidien LP · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls3 reports
- McKesson S661GXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
- Surgilon 88861919-41Covidien LP · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls2 reports
- McKesson S931BXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
- McKesson S697GXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls1 report
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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