Device product
Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000 32810600012 32810600013 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510822 32855510843 32855510844
Z-0301-2020
Product summary
- Event
- Event 83962
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,459,583 total devices
- Official record key
device-enforcement:Z-0301-2020
Official wording
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Code information: All product manufactured prior to January 2014.
Distribution pattern: Distributed nationwide.
Derived failure modes
-
Unknown
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).