medical Class II Updated 2021-06-16

Alphatec Spine, Inc. recalls Atec Insignia Anterior Cervical Plate System, REF 136-0118,

Recalled Product

Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446

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: 8609303R and 8800403
View official government recall

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