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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

OsteoSurge 100 Bone Matrix Recalled for Incorrect Expiration Dates

Agency Publication Date: January 16, 2025
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Summary

IsoTis OrthoBiologics, Inc. has recalled 22 units of OsteoSurge 100 Demineralized Bone Matrix Putty (10cc) because the expiration date listed on the outer box is incorrect. The date on the box does not match the earlier, correct expiration date printed on the product's inner tray. The recall affects medical distributors and hospitals in Indiana, Tennessee, and Texas. No injuries or incidents have been reported.

Risk

Using medical putty past its actual expiration date may result in a product that is no longer effective or safe for surgical use. Because the outer box shows a later date than the inner tray, there is a risk that the product could be used after it has technically expired.

What You Should Do

  1. This recall affects OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix (10cc, REF 56300100) from Lot 1031907 and Lot 1031825.
  2. Identify affected products by checking the lot numbers and expiration dates on the packaging. Affected items include Lot 1031907 (Box Exp 2025-11-28 / Tray Exp 2024-11-28) and Lot 1031825 (Box Exp 2025-07-28 / Tray Exp 2025-03-28).
  3. Stop using the recalled product immediately.
  4. Contact the manufacturer, IsoTis OrthoBiologics, Inc., or your medical distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, 10cc
Variants: 10cc
Model / REF:
56300100
Lot Numbers:
1031907 (Box Exp 2025-11-28 / Tray Exp 2024-11-28)
1031825 (Box Exp 2025-07-28 / Tray Exp 2025-03-28)
UDI:
10889981055820

Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95981
Status: Active
Manufacturer: IsoTis OrthoBiologics, Inc.
Sold By: Specialized medical distributors; Hospitals
Manufactured In: United States
Units Affected: 22
Distributed To: Indiana, Tennessee, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.