Vitoss BA 2102-1601Recalls & reported problems
Stryker Corporation · Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, and Bioactive Glass · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00808232000498), received between Sep 14, 2016 and Sep 14, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Expiration Issue” (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 Expiration Issue1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2016Device Expiration Issue
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS IMPLANTED INTO PATIENT.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 5951327 ↗
Other FILLER, BONE VOID, CALCIUM COMPOUND devices
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42275Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls1 report
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44150Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls1 report
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42200Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42280Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44145Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T43102Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- MAGNIFUSE® Bone Graft 7509014Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- HydroSet XT 897005Stryker Corporation · FILLER, BONE VOID, CALCIUM COMPOUND1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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