Stryker Spine recalls AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbo…

Recall date

August 23, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3210-2024

FDA classification

Class II

Brand / firm

Stryker Spine

Sold / distributed

Worldwide distribution - US Nationwide and the country of Canada.

Why it was recalled

Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.