OPT Croutons is a synthetic bone substitute designed recall
OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium…
Why was OPT Croutons is a synthetic bone substitute designed 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
lot 549/12.001. Part number 65-0210-S.
- Product
- OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium…
- Recalling firm
- Acumed LLC
- Quantity
- 83 units distributed in the US
- Distribution
- distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
- Recall date
- January 18, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)