medical Class II Updated 2021-06-16

Alphatec Spine, Inc. recalls Atec Insignia Anterior Cervical Plate System, REF 136-0240 I

Recalled Product

Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408


Hazard / Issue

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 8663401R, 8609316R
View official government recall

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