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PDS Z515GRecalls & reported problems

Ethicon, LLC · Undyed 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 10705031061378), received between Apr 24, 2019 and Apr 24, 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. 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 24, 2019Break; Break

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP WAS BENT AND IT WAS ALMOST BROKEN DURING USE. UPON EVALUATION OF THE DEVICE, A FRACTURE WAS OBSERVED AT THE TIP OF THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8546330 ↗

Other Suture, surgical, absorbable, polydioxanone devices

All Suture, surgical, absorbable, polydioxanone devices →

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