Hu-Friedy Mfg. Co., LLC PSN535FARecalls & reported problems
Hu-Friedy Mfg. CO., LLC · 4-0 UNDYED PGAFA SUTURE 18", C-6 NEEDLE 18.7 MM, 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 10889950001452), received between Feb 1, 2019 and Feb 1, 2019 — 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
- 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.
MalfunctionFeb 1, 2019Detachment of Device or Device Component
IT WAS REPORTED THE NEEDLE DETACHED FROM PGA SUTURE AFTER INITIAL PASS THROUGH TISSUE. THERE WAS NO INDICATION OF THE PATIENT EXPERIENCING AN ADVERSE EVENT. THE SUTURE INVOLVED CAME FROM LOT# 180108-63.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8298485 ↗
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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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