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IsoTis OrthoBiologics, Inc. FDA Recalls
3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095Class IIJul 2, 2026Demineralized bone matrix (DBM) in resorbable mesh indicated |
| OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, Class IINov 27, 2024Incorrect expiration date listed on the outer box, which doe |
| OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.Class IINov 27, 2024Hydration issue resulting in the product being less cohesive |