Corin Ltd: Medical Device Recall in 2021 - (Recall #: Z-2611-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 28, 2021

Date Posted: October 6, 2021

Recall Number: Z-2611-2021

Event ID: 88589

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.

Status: Terminated

Product Quantity: 2 units

Code Information:

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 1125182 - Lot number 477942 was delivered 7/22/2021; model 1125243 - Lot number 479310 was delivered 7/23/2021.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated