FDA Enforcement
Class II
Ongoing
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.
Recall: Z-3210-2024
·
Reported October 2, 2024
Enforcement
- Recall Number
- Z-3210-2024
- Event ID
- 95274
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker Spine
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 2, 2024
- Initiation Date
- August 23, 2024
- Classification Date
- September 23, 2024
- Address
- 2 Pearl Ct, Allendale, NJ, 07401-1611, United States
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
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 Info
electronic eIFU (revision 5) Rev 5 available January 2023 to present.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Quantity
8,589 units