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Vitoss BA 2102-1520Recalls & reported problems

Stryker Corporation · Bioactive Bone Graft Substitute, Foam Strip; Beta-Tricalcium Phosphate, Type I Bovine Collagen, and Bioactive Glass · 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 00808232000481), received between Aug 6, 2020 and Aug 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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

  • Failure to Osseointegrate1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • 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.

  • MalfunctionAug 6, 2020Failure to Osseointegrate; Failure to Osseointegrate

    IT WAS REPORTED THAT PREVIOUSLY IMPLANTED VITOSS BIOACTIVE FOAM STRIP "HAS YET TO HARDEN" AND THERE WAS NO NEW BONE GROWTH POST-OPERATIVELY. NO FURTHER INFORMATION, ADVERSE CONSEQUENCES, OR MEDICAL INTERVENTION WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 10374991 ↗

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.