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RIVERLON 663BKRecalls & reported problems

Riverpoint Medical, LLC · SUTURE · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812444020779), received between Aug 31, 2022 and Dec 20, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 16, 2026.

Most reported problems

Device problems

  • Device Contamination with Chemical or Other Material1
  • Unsealed Device Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 20, 2022Unsealed Device Packaging; Unsealed Device Packaging

    ACCORDING TO THE REPORTER, "RECEIVED SOME POUCHES THAT WERE IMPROPERLY SEALED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16019300 ↗
  • MalfunctionAug 31, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    ACCORDING TO THE REPORTER, "BROWN SPOTS ON THREE PACKETS ON 500131 LOT 21090113. SOME OF IT IS GRAINY AND SOME OF IT SMEARS WHEN TOUCHED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15329057 ↗

Other Suture, Nonabsorbable, Synthetic, Polyamide devices

All Suture, Nonabsorbable, Synthetic, Polyamide devices →

Sources and updates

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