FDA-Device2021-06-16Class II
Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
Alphatec Spine, Inc.
Hazard
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Sold states
US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.
Affected count
26 units
Manufactured in
1950 Camino Vida Roble, N/A, Carlsbad, CA, United States
Products
Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1811-2021Don't want to check this manually?
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