IsoTis OrthoBiologics recalls
IsoTis OrthoBiologics has 3 recalls on record with the FDA and USDA, the earliest in 2025 and the latest reported on 5 Aug 2026. 3 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is lead & heavy metals.
Total recalls3since 2025
Last 12 months1reported
Class I00% of total
Ongoing3latest 5 Aug 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 3 100%Class III 0 0%
Why isotis orthobiologics is recalled
Product types
By year
Ongoing isotis orthobiologics recalls
3 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OsteoBallast, mm (SeaSpine Brand) recalled by IsoTis OrthoBiologics | IsoTis OrthoBiologics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | OsteoCove Putty, 25cc recalled by IsoTis OrthoBiologics | IsoTis OrthoBiologics | Other | Nationwide |
| Device | CLASS II | OsteoSurge 100 Demineralized Bone Matrix Putty recalled | IsoTis OrthoBiologics | Device Malfunction | Nationwide |
All isotis orthobiologics recalls, newest first
3 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OsteoBallast, mm (SeaSpine Brand) recalled by IsoTis OrthoBiologics | IsoTis OrthoBiologics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | OsteoCove Putty, 25cc recalled by IsoTis OrthoBiologics | IsoTis OrthoBiologics | Other | Nationwide |
| Device | CLASS II | OsteoSurge 100 Demineralized Bone Matrix Putty recalled | IsoTis OrthoBiologics | Device Malfunction | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.