Z-0273-2023 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 30, 2022
- Initiation Date
- October 31, 2022
- Termination Date
- January 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 devices
Product Description
Unity Total Knee System. Used for knee prosthesis in total knee replacement
Reason for Recall
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
Distribution Pattern
Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
Code Information
Model Number: 112.040.06; Lot Number: 504337