Z-0702-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 16, 2019
- Initiation Date
- November 16, 2018
- Termination Date
- November 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 182 packs
Product Description
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
Reason for Recall
The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
Distribution Pattern
US state of Florida
Code Information
Product code: SOP22TJCLK Lot numbers # 104405, 122793, and 987948