OsteoBallast 45 x 17.5 mm
IsoTis recalls OsteoBallast 45 x 17.5 mm DBM mesh due to underfill, risking incomplete fusion.
If you have an OsteoBallast (SeaSpine Brand, REF 56800095) or Ballast (IsoTis Brand, REF 02-8000-095) 45 x 17.5 mm product, stop using it and contact IsoTis OrthoBiologics for return and replacement.
Why it was recalled
IsoTis OrthoBiologics is recalling OsteoBallast and Ballast demineralized bone matrix (DBM) in resorbable mesh, sizes 45 x 17.5 mm, because they were filled with approximately 4.5 cc of DBM (the fill for the 45 x 11 mm configuration) instead of the required 7.5 cc. This underfill may lead to delayed or incomplete fusion, pseudarthrosis, or lack of bone ingrowth.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
- Lot code
- 56800095, 181559, 181550, 02-8000-095
- UDI-DI
- 56800095, 10889981149352, 10889981149314
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Editorial summary by Recall Canary · summary updated 2026-07-29 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification