CLASS II ONGOING Device recall · Reported 2 Oct 2024 · FDA Enforcement Report
AVS Anchor-C Cervical Cage System Instructions For Use recalled
Stryker Spine is recalling AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision -Indicated, distributed nationwide in the US. The recall was initiated on 23 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3210-2024
- FDA event ID
- 95274
- Recalling firm
- Stryker Spine, Allendale, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Aug 2024
- FDA classified
- 23 Sep 2024
- Reported
- 2 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 23 Aug 2024 | Recall initiated by company | |
| 23 Sep 2024 | Classified by FDA | +31 days |
| 2 Oct 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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 as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
electronic eIFU (revision 5) Rev 5 available January 2023 to present.
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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