Z-2611-2021 Class II Terminated
FDA device recall Z-2611-2021 was initiated by Corin Ltd on July 28, 2021 and is designated Class II. 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. The recall status is terminated (terminated June 12, 2024). Affected quantity: 2 units.
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
- 2 units
Product Description
Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size 8 / 10.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125243, Sterile, both are components 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. Model 1125182 - Lot number 477942 was delivered 7/22/2021; model 1125243 - Lot number 479310 was delivered 7/23/2021.