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Recall Observatory FDA recall evidence

Device product

Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4 42 insert/28 head, REF 325.04.042, Sterile; both are components of the Trinity Dual Mobility System.

Z-2608-2021

July 28, 2021

Class II

Product summary

Firm
Corin Ltd
Event
Event 88589
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-2608-2021

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 321.04.540 - Lot number 478880 delivered 7/26/2021; Model 325.04.042- Lot number 480567 delivered 7/26/2021.

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