Stryker Spine recalls its AVS Anchor-C Cervical Cage System (revision 5) due to a labeling error in instructions for use. This correction affects U.S. and Canadian patients using the device for cervical fusion procedures.
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.
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📍Recalling firmStryker Spine2 Pearl Ct · Allendale, NJ 07401-1611
✎ GovInfoNow plain-language explainer
Stryker Spine is recalling its AVS Anchor-C Cervical Cage System (revision 5) because the electronic instructions for use had a labeling error that removed specific language about intended use. This correction does not affect safety but ensures proper medical use for cervical fusion procedures. Read more at govinfonow.com/recall/54173-stryker-spine-avs-anchor-c-cervical-cage-system-labeling-correction.
“Stryker Spine AVS Anchor-C Cervical Cage System: Labeling Correction Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54173-stryker-spine-avs-anchor-c-cervical-cage-system-labeling-correction. Based on FDA recall #Z-3210-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3210-2024%22&limit=1).
The FDA announced on August 23, 2024, that Stryker Spine is recalling its AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5) due to labeling corrections. The hazard involves inadvertently removed language for indications for use in the United States and Canada.
How to tell if you have it
Brand: Stryker Sp: Spine
Product: AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)
Quantity: 8,589 units
The hazard
The electronic IFU (revision 5) available from January 2023 to present lacks specific language for indications for use for the United States and Canada. The product is 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.
Context
GovInfoNow's records show Stryker Spine has issued five other recalls since August 13, 2018. Other recent recalls include a February 28, 2025 Monterey AL Implant Inserter Recall and a November 1, 2023 LITe Decompression Snake Arm Recall. Similar product recalls in March 2026 involved Centinel Spine Prodisc C SK U.S. Implant labeling errors and XTANT Medical Xpress Pedicle Screw System incorrect labeling risks.
How to tell if you have this one
Check if you have the AVS Anchor-C Cervical Cage System with electronic instructions for use (eIFU) revision 5, which was released in January 2023 or later. This device is used for anterior cervical fusion procedures in patients with cervical disc disease.
Brand
Stryker Sp: Spine
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Review Instructions
Check if your device has the electronic instructions for use (eIFU) revision 5, which was released in January 2023 or later.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3210-2024 (August 23, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3210-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.