OsteoBallast and Ballast bone graft extenders recalled due to insufficient material volume
IsoTis OrthoBiologics, Inc. is recalling OsteoBallast and Ballast bone graft extenders because they may contain less demineralized bone matrix than intended.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The product is a high-risk medical device where the defect (insufficient graft material) poses a risk of harm (failure of bone fusion) but no injuries have been reported in the source text.
Plain-English summary
IsoTis OrthoBiologics, Inc. is recalling OsteoBallast (SeaSpine Brand, REF: 56800095) and Ballast (IsoTis Brand, REF: 02-8000-095) bone graft extenders. These products are demineralized bone matrix (DBM) in resorbable mesh, intended for use with autograft as a bone graft extender in the posterolateral spine and pelvis.
The products were filled with approximately 4.5 cc of DBM instead of the intended approximately 7.5 cc for the 45 x 17.5 mm configuration. This insufficient volume may lead to delayed fusion, incomplete fusion, pseudarthrosis, or a lack of bone ingrowth.
This recall affects products distributed nationwide in the United States, specifically in AK, NJ, TN, AR, CA, and WA.
The recalled product
- Product
- OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
- Manufacturer
- IsoTis OrthoBiologics, Inc.
- Affected units
- 98
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- REF/UDI-DI/Lots: 56800095/10889981149352/181559
- 181550 02-8000-095/10889981149314/181559
- 181550
Distribution
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