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Alphatec Spine, Inc. recalls Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01
Recalled June 16, 2021 · FDA recall Z-1819-2021 · Alphatec Spine
Hazard
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. · FDA Class II
Units
5 units
Sold at
US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.
Description
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590
Manufacturer(s)
Alphatec Spine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →