Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OPT Croutons is a synthetic bone substitute designed for the Recalled by Acumed LLC Due to OPT Croutons, part number 65-0210-S, is recalled due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Acumed LLC directly.
Affected Products
OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.
Quantity: 83 units distributed in the US
Why Was This Recalled?
OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product sterilized at the site did not receive the minimum dose required per the new performance qualification.
Where Was This Sold?
This product was distributed to 9 states: FL, IN, KS, MI, MO, NE, OH, PA, TX
About Acumed LLC
Acumed LLC has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report