Device product
Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity Total Knee System.
Z-2612-2021
Product summary
- Firm
- Corin Ltd
- Event
- Event 88589
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-2612-2021
Official wording
Reason: 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.
Code information: The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 473755 was delivered 7/26/2021.
Distribution pattern: US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
Derived failure modes
-
Sterility assurance
loss of sterility