Device product
SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 47235802106 47235802108 47235802203 47235802204 47235802206 47235802208 47235802210
Z-0311-2020
Product summary
- Event
- Event 83962
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,459,583 total devices
- Official record key
device-enforcement:Z-0311-2020
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).