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NuOss 5099250Recalls & reported problems

Ace Surgical Supply CO., Inc. · NUOSS COLLAGEN 8X9X9MM APPROXIMATELY 250MG · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00614950007523), received between Mar 18, 2022 and Mar 18, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Inaccurate Information” (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

  • Inaccurate Information1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryMar 18, 2022Inaccurate Information; Inaccurate Information

    IT WAS REPORTED THAT THE INCORRECT PRODUCT WAS IN THE BOX. AS PER THE DISTRIBUTOR'S REPRESENTATIVE FROM THE REPORTING FACILITY, THEY STATED TWO PATIENTS WERE TREATED WITH THE MISLABELED PRODUCT, COLLATENE FIBRILLAR COLLAGEN RATHER THAN NUOSS COLLAGEN BLOCK. A HHE CONDUCTED BY THE DISTRIBUTOR AND COLLAGEN MATRIX CONFIRMED THE HEALTH RISK IS LOW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13806244 ↗

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