Z-1823-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 16, 2021
- Initiation Date
- April 26, 2021
- Termination Date
- November 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 units
Product Description
Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
Reason for Recall
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Distribution Pattern
US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.
Code Information
8609329R