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.
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.
The labeling error removed specific language about the device's intended use for cervical fusion procedures. This could lead to improper application if the instructions are not followed correctly. However, the device itself remains safe for its intended medical purpose.
Patients who have received the AVS Anchor-C Cervical Cage System (revision 5) for anterior cervical fusion procedures in the U.S. or Canada are affected. Surgeons and medical staff using this device for cervical disc disease treatment are most at risk of using incorrect instructions.
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.
Check if your device has the electronic instructions for use (eIFU) revision 5, which was released in January 2023 or later.
No, this recall is for a labeling correction only. The device itself is safe but the instructions for use were updated to ensure proper medical application.
No, you do not need to stop using the device. The recall is for a labeling correction, not a safety hazard.
Review the electronic instructions for use (eIFU) revision 5 to confirm it matches your device. No action is needed beyond this check.
We’ve drafted a message you can send Stryker Sp: Spine to request your refund or repair — edit it as you like.
Subject: Recall Z-3210-2024 — Stryker Sp: Spine Stryker Sp: Spine Hello, I own a Stryker Sp: Spine that is covered by recall Z-3210-2024 from Stryker Sp: Spine. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
