OsteoSurge 100 Demineralized Bone Matrix Putty with Accell… recallZ-0955-2025 · IsoTis OrthoBiologics, Inc. · initiated Nov 27, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from IsoTis OrthoBiologics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
FDA root cause category: Labeling Change Control
What the company is doing
An Urgent Medical Device Recall notice was issued via email 11/27/2024. The notice advised consignees to either use the product by the expiration date listed in the notice or return the affected part(s) using provided shipping label and complete and return the Acknowledgement and Receipt Form as soon as possible. Direct questions regarding this matter to Danielle Becker at [email protected] or Danielle Nelson-Archer at [email protected].
Recall details
- Recall number
- Z-0955-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 27, 2024
- Posted by the FDA
- Jan 16, 2025
- Recalling firm
- IsoTis OrthoBiologics, Inc.
- Quantity
- 22
- Product code
- MQV
- FDA submissions
- K242273
- Distribution
- US Nationwide distribution in the states of IN, TN & TX.
Product description
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Code information (models, lots, serial 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)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OsteoSurge 100 Putty 56300100Isotis Orthobiologics, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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