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Recall Observatory FDA recall evidence

Device 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.

Z-2611-2021

July 28, 2021

Class II

Product summary

Firm
Corin Ltd
Event
Event 88589
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-2611-2021

Official wording

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.

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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    loss of sterility