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PDS Z451HRecalls & reported problems

Ethicon, LLC · Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture · Class 2 · Implant

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 10705031061019), received between Apr 2, 2020 and Apr 2, 2020 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 2, 2020Break; Break

    IT WAS REPORTED THAT A DOG UNDERWENT A SURGICAL PROCEDURE (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9918726 ↗

Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.