FDA Medical devices recall ·
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix… recall
- Recall number
- Z-0955-2025
- Date
- (initiated November 27, 2024)
- Company / brand
- IsoTis OrthoBiologics, Inc.
2 Goodyear Ste A, Irvine, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 22
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Why was it recalled?
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 10889981055820, Lot 1031907, Exp. 2025-11-28 (Inner Tray Exp. 2024-11-28) and Lot 1031825, Exp. 2025-07-28 (Inner tray Exp. 2025-03-28)
Distribution
US Nationwide distribution in the states of IN, TN & TX.
States: Indiana Tennessee Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0955-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.