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Vitoss BA 2102-1605Recalls & reported problems

Stryker Corporation · Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, and Bioactive Glass · 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 00808232000511), received between Mar 7, 2017 and Mar 7, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (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

  • Biocompatibility1
  • Material Protrusion/Extrusion1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryMar 7, 2017Biocompatibility; Material Protrusion/Extrusion; Biocompatibility

    IT WAS REPORTED THAT; DURING A FOLLOW UP VISIT THE PATIENT PRESENTED WITH AN INFECTION. PRODUCT WAS PROTRUDING OUT OF THE WOUND.

    Patient problems: Unspecified Infection

    MAUDE report 6384294 ↗

Other FILLER, BONE VOID, CALCIUM COMPOUND devices

All FILLER, BONE VOID, CALCIUM COMPOUND devices →

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