Stryker Spine: Device Recall
Recall #Z-3210-2024 · 08/23/2024
Class II: Risk
Recall Details
- Recall Number
- Z-3210-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Stryker Spine
- Status
- Ongoing
- Date Initiated
- 08/23/2024
- Location
- Allendale, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,589 units
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.
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Other Recalls by Stryker Spine
- Class II: Risk 02/28/2025
- Class II: Risk 02/28/2025
- Class II: Risk 02/28/2025
- Class II: Risk 02/28/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.