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
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
loss of sterility