Hu-Friedy Mfg. Co., LLC PSN8683PRecalls & reported problems
Hu-Friedy Mfg. CO., LLC · 4-0 BLUE POLYPROPYLENE SUTURE 18", C-6 NEEDLE 18.7MM, 3/8 CIRCLE 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 10889950001919), received between Sep 6, 2019 and Sep 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionSep 6, 2019Break
IT WAS REPORTED SIZE 4/0 POLYPROPYLENE SUTURE BREAKING DURING SURGERY, AFTER IMPLANT AND GRAFTING. (LOT# 180612-67) THERE WAS PATIENT INVOLVEMENT WITH A HEALTHY MIDDLE-AGED MALE BUT NO INDICATION OF AN ADVERSE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8970341 ↗
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- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 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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