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DirectOss™ DXCA251025Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · Anorganic Bovine Cancellous Bone (250-1000µm) - 0.25g · 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 10841307122562), received between May 15, 2019 and May 15, 2019 — classified as 1 malfunction.

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 Patient Involvement1

Recent adverse event reports

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

  • MalfunctionMay 15, 2019Inaccurate Information; Inaccurate Information

    PER COMPLAINT (B)(4), IT WAS REPORTED THAT BONE GRAFT PRODUCT WAS MISLABELED. THE LOT NUMBER ON THE LABEL ON THE BOX WAS MISSING A DIGIT AT THE END.

    Patient problems: No Patient Involvement

    MAUDE report 8613598 ↗

Other Bone Grafting Material, Animal Source devices

All Bone Grafting Material, Animal Source devices →

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