PlainRecalls
FDA Devices Moderate Class II Terminated

Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.

Reported: October 6, 2021 Initiated: July 28, 2021 #Z-2610-2021

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.

Details

Recalling Firm
Corin Ltd
Units Affected
1 unit
Distribution
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
Location
Cirencester, N/A

Frequently Asked Questions

What product was recalled?
Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.. Recalled by Corin Ltd. Units affected: 1 unit.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 6, 2021. Severity: Moderate. Recall number: Z-2610-2021.