OsteoBallast recall
IsoTis OrthoBiologics, Inc. recalled OsteoBallast on August 5, 2026 because of 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. It was sold nationwide.
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.
What's recalled
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Quantity: 98
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- IsoTis OrthoBiologics, Inc., Irvine, CA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH. - Status
- Ongoing
- Recall number
- Z-2820-2026
- Source
- U.S. Food and Drug Administration
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