Device product
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Z-0955-2025
Product summary
- Event
- Event 95981
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 22
- Official record key
device-enforcement:Z-0955-2025
Official wording
Reason: Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
Code information: 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 pattern: US Nationwide distribution in the states of IN, TN & TX.
Derived failure modes
-
Unknown
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.