OsteoBallast 56800095Recalls & reported problems
Isotis Orthobiologics, Inc. · OsteoBallast, 45x17.5mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Jul 2, 2026Open, Classified
Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.
Z-2820-2026 · Root cause: Process control · FDA record ↗
Other Filler, bone void, osteoinduction (w/o human growth factor) devices
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T45010Medtronic Sofamor Danek, Inc. · Filler, bone void, osteoinduction (w/o human growth factor)2 recalls2 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44135Medtronic Sofamor Danek, Inc. · Filler, bone void, osteoinduction (w/o human growth factor)2 recalls1 report
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44115Medtronic Sofamor Danek, Inc. · Filler, bone void, osteoinduction (w/o human growth factor)2 recalls1 report
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42210Medtronic Sofamor Danek, Inc. · Filler, bone void, osteoinduction (w/o human growth factor)2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42100Medtronic Sofamor Danek, Inc. · Filler, bone void, osteoinduction (w/o human growth factor)2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T45001Medtronic Sofamor Danek, Inc. · Filler, bone void, osteoinduction (w/o human growth factor)2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T45005Medtronic Sofamor Danek, Inc. · Filler, bone void, osteoinduction (w/o human growth factor)2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T43105Medtronic Sofamor Danek, Inc. · Filler, bone void, osteoinduction (w/o human growth factor)1 recall4 reports
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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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