AVS Anchor-C Cervical Cage System Instructions For Use recall: Labeling Error
AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in…
Why was AVS Anchor-C Cervical Cage System Instructions For Use 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
electronic eIFU (revision 5) Rev 5 available January 2023 to present.
- Product
- AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in…
- Recalling firm
- Stryker Spine
- Quantity
- 8,589 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall date
- October 2, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)