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IsoTis OrthoBiologics Recalls
3 recalls on record · January 22, 2025 to August 5, 2026 · Medical Devices
Recalls by year
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 5, 2026Medical DevicesFDA
IsoTis OrthoBiologics, Inc. recalls OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
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.
January 22, 2025Medical DevicesFDA
IsoTis OrthoBiologics, Inc. recalls OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc,
Hazard: Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
January 22, 2025Medical DevicesFDA
IsoTis OrthoBiologics, Inc. recalls OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Hazard: Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.