Z-2610-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- July 28, 2021
- Termination Date
- June 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.
Reason for Recall
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
Code Information
The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 472687 was delivered 7/23/2021.