Z-1019-2017 Class II Terminated
FDA device recall Z-1019-2017 was initiated by Acumed LLC on December 5, 2016 and is designated Class II. 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 … The recall status is terminated (terminated March 22, 2017). Affected quantity: 83 units distributed in the US.
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2017
- Initiation Date
- December 5, 2016
- Termination Date
- March 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 units distributed in the US
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.
Distribution Pattern
distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
Code Information
lot 549/12.001. Part number 65-0210-S.