Isotis Orthobiologics, Inc.: Filler, Bone Void, Calcium Compound
Recall Summary IsoTis OrthoBiologics is recalling OsteoBallast and Ballast bone graft products (45 x 17.5 mm sizes) because they contain less bone material than intended—approximately 4.5 cc instead of 7.5 cc. This underfill could result in delayed or incomplete bone fusion, pseudarthrosis (failed fusion), or inadequate bone growth after spinal or pelvic surgery. The products were distributed nationwide to hospitals and surgical facilities.
- Recalling firm
- IsoTis OrthoBiologics, Inc.
- Product
- OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-02
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/75f8a9b2-c1a9-468c-ad05-5771f92233ff