AVS Anchor-C Cervical Cage System Instructions For Use — Class II medical device recall Z-3210-2024
Ongoing recall by Stryker Spine, reported 2024-10-02, distributed nationwide. Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications fo
| Recall number | Z-3210-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Spine, Allendale, NJ, United States |
| Recall initiated | 2024-08-23 |
| Classified | 2024-09-23 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 8,589 units |
| Reason classes | labeling |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3210-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.