Demineralized Bone Matrix Putty Recalled for Incorrect Outer Box Expiration Date
IsoTis OrthoBiologics recalls OsteoSurge 100 Demineralized Bone Matrix Putty due to incorrect expiration dates on outer packaging. The outer box date does not match the correct date on the inner tray.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for a minor labeling error—the outer box expiration date does not align with the correct inner tray expiration date. No illnesses or injuries have been reported. The risk remains theoretical. This fits the Moderate classification: minor labeling errors without reported adverse events.
Plain-English summary
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix (10cc, REF 56300100) is being recalled by manufacturer IsoTis OrthoBiologics, Inc. A total of 22 units are affected.
The recall was initiated because the expiration date printed on the outer box is incorrect and does not match the true expiration date listed on the inner tray. This labeling discrepancy could lead users to rely on inaccurate dating information when determining product usability.
Affected units were distributed nationwide in Indiana, Tennessee, and Texas. The specific lot numbers involved are 1031907 (with outer box expiration 2025-11-28 but inner tray expiration 2024-11-28) and 1031825 (with outer box expiration 2025-07-28 but inner tray expiration 2025-03-28).
Healthcare facilities and users who have received affected units should verify the expiration date on the inner tray packaging rather than relying on the outer box label.
The recalled product
- Product
- OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
- Manufacturer
- IsoTis OrthoBiologics, Inc.
- Hazard
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
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