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.
Reported: January 18, 2017 Initiated: December 5, 2016 #Z-1019-2017
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Acumed LLC
- Units Affected
- 83 units distributed in the US
- Distribution
- distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
- Location
- Hillsboro, OR
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Acumed LLC. Units affected: 83 units distributed in the US.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2017. Severity: Moderate. Recall number: Z-1019-2017.
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