Z-3210-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2024
- Initiation Date
- August 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,589 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
electronic eIFU (revision 5) Rev 5 available January 2023 to present.