Reported Aug 5, 2026 · Ongoing
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
IsoTis OrthoBiologics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: IsoTis OrthoBiologics, Inc. · 2 Goodyear Ste A · Irvine, CA · 92618-2052
Is this the product you have?
- OsteoBallast, 45 x 17.5 mm (SeaSpine Brand)
- REF
56800095. Ballast45 x 17.5 mm (IsoTis Brand)
- REF02-8000-095
- Lot codes and dates
- REF/UDI-DI/Lots
56800095/10889981149352/181559181550 02-8000-095/10889981149314/181559181550
- REF/UDI-DI/Lots
- Amount recalled
- 98
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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