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Alphatec Spine, Inc. recalls Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01
Recalled June 16, 2021 · FDA recall Z-1810-2021 · 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
19 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 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392
Manufacturer(s)
Alphatec Spine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →