FDA recall Z-2611-2021

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 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

US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.

Key facts

Status

Terminated

Initiation date

2021-07-28

Report date

2021-10-06

Termination date

2024-06-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cirencester, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2611-2021