No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
No image published for this recall
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Official notice
5 Aug 2026
Last checked
22 Sept 2026
An official FDA notice concerns Isotis Orthobiologics. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2026-08-05. Recall numbers: Z-2820-2026. Check the official notice for the complete list.
What to do now
Instructions for consumers are available in the official FDA notice.
Units affected
98
Recall number
Z-2820-2026
Official notice
2026-08-05
The hazard
The hazard
Chemical exposure risk
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Event Ids
Recall Numbers
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Isotis Orthobiologics. Contact: IsoTis OrthoBiologics, Inc..
Source & status
Source & status
Recall details
Recall details
Recall number
Event id
Units affected
Status
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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