Corin Unity Knee Patella recall: Sterility Concern
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.
Why was Corin Unity Knee Patella recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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.
- Recalling firm
- Corin Ltd
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
- Recall date
- October 6, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)