FDAFDA · Food and drugs·Recall number Z-1019-2017
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.
Published January 18, 2017 · Recall initiated: December 5, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Acumed LLC
- Distributor
- distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
- Lot
- lot 549/12.001. Part number 65-0210-S.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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