FDAFDA · Food and drugs·Recall number Z-3210-2024
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.
Published October 2, 2024 · Recall initiated: August 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Spine
- Distributor
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot
- electronic eIFU (revision 5) Rev 5 available January 2023 to present.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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