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

Recalled October 2, 2024 · FDA recall Z-3210-2024 · Stryker Spine

Hazard

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. · FDA Class II

Units

8,589 units

Sold at

Worldwide distribution - US Nationwide and the country of Canada.

Description

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.

Product

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.

Manufacturer(s)

Stryker Spine

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →