United StatesOsteoBallast 45 x 17.5 mm (SeaSpine Brand, REF 56800095) and Ballast 45 x 17.5 mm (IsoTis Brand, REF 02-8000-095), lots 181559 and 181550, are affected; units were distributed nationwide in AK, NJ, TN, AR, CA, WA, and OH. The devices were filled with approximately 4.5 cc of demineralized bone matrix instead of the intended approximately 7.5 cc, which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.
What's being recalled
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Recalling firm: IsoTis OrthoBiologics, Inc., Irvine, CA, United States.
How to identify it
REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)