Recall Z-2611-2021— Corin Ltd

Name: FDA recall Z-2611-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-28

Class II · Terminated

Class II FDA medical device recall by Corin Ltd, initiated 2021-07-28, terminated 2024-06-12. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..

Recalling firm: Corin Ltd
Classification: Class II
Status: Terminated
Initiated: 2021-07-28
Terminated: 2024-06-12
Firm location: Cirencester, N/A, United Kingdom

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.