Z-0311-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2019
- Initiation Date
- October 10, 2019
- Termination Date
- May 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,459,583 total devices
Product Description
SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 47235802106 47235802108 47235802203 47235802204 47235802206 47235802208 47235802210
Reason for Recall
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Distribution Pattern
Distributed nationwide.
Code Information
All product manufactured prior to January 2014.