IsoTis OrthoBiologics, Inc.: Device Recall
Recall #Z-0955-2025 · 11/27/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0955-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- IsoTis OrthoBiologics, Inc.
- Status
- Ongoing
- Date Initiated
- 11/27/2024
- Location
- Irvine, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22
Reason for Recall
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
Product Description
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Distribution Pattern
US Nationwide distribution in the states of IN, TN & TX.
Other Recalls by IsoTis OrthoBiologics, Inc.
- Class II: Risk 11/27/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.