Device product
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.
Z-3210-2024
Product summary
- Firm
- Stryker Spine
- Event
- Event 95274
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,589 units
- Official record key
device-enforcement:Z-3210-2024
Official wording
Reason: 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.
Code information: electronic eIFU (revision 5) Rev 5 available January 2023 to present.
Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.
Derived failure modes
-
Unknown
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.