IsoTis OsteoSurge Bone Matrix Putty: Incorrect Expiration Date on Packaging
IsoTis recalls OsteoSurge 100 Demineralized Bone Matrix Putty due to incorrect expiration date listed on the outer box compared to inner tray. This could lead to using expired product.
Lower-risk recall
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
Contact the company
What happened, in plain English
IsoTis is recalling OsteoSurge 100 Demineralized Bone Matrix Putty because the outer box shows an incorrect expiration date compared to the inner tray. Using expired product could lead to ineffective treatment or safety risks. Read more at govinfonow.com/recall/53382-isotis-osteosurge-bone-matrix-putty-incorrect-expiration-date-on-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/53382-isotis-osteosurge-bone-matrix-putty-incorrect-expiration-date-on-packaging · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0955-2025
Cite this page
“IsoTis OsteoSurge Bone Matrix Putty: Incorrect Expiration Date on Packaging.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53382-isotis-osteosurge-bone-matrix-putty-incorrect-expiration-date-on-packaging. Based on FDA recall #Z-0955-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0955-2025%22&limit=1).
Why it’s dangerous
The outer box lists an expiration date that does not match the inner tray's expiration date. This mismatch could mean the product is expired before the intended use date, potentially leading to ineffective treatment or safety issues.
Who’s affected
Patients using OsteoSurge 100 Demineralized Bone Matrix Putty for medical procedures. Those who have the product with the specific lot numbers and expiration dates listed in the recall are most at risk.
How to tell if you have this one
Check the outer box for the product name and lot number. Look for the specific lot numbers: 1031907 (exp. 2025-11-28) and 1031825 (exp. 2025-07-28).
- Brand
IsoTis- Category
Medical device
What to do — step by step
Check Product Expiration
Verify the expiration date on the inner tray matches the intended use date. If not, contact the manufacturer.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “US Nationwide distribution in the states of IN, TN & TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Indiana, Tennessee, Texas.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0955-2025 (November 27, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0955-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.