Z-3210-2024Class II

AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior...

Name: Z-3210-2024 AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior...
Creator: Stryker Spine
Published: 2024-08-23
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2024-08-23 / Open, Classified / root cause: labeling and UDI

FDA source

Stryker Spine began a recall of AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally... on 2024-08-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3210-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-23
Posted: 2024-09-23
Recalling firm: Howmedica Osteonics Corp
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.
Product code: OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Stryker issued Medical Device Correction letter on 8/23/24 to Surgeons via Fed'X. Letter states reason for recall, health risk and action to take: Our records indicate that you are a new user of the AVS-Anchor C system since the eIFU was updated to Revision 5 in January 2023. Please review the Product Correction Notification and the updated eIFU (Revision 6). This communication is being made for notification purposes only; there are no product(s) to be returned for this matter. 2. Use the Business Reply Form to acknowledge receipt of this notification letter. 3. Return the enclosed Business Reply Form by email to: [email protected] to confirm receipt of this notification. 4. If you desire additional training associated with these instructions, please contact our Regulatory Compliance team by calling 201.749.8090 or by email at [email protected], or contact your local Sales representative. Completing this action by the target date September 13, 2024 and regret any inconvenience that may be caused
Quantity in commerce: 8,589 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: electronic eIFU (revision 5) Rev 5 available January 2023 to present.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3210-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3210-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-23

Product code OVE

K102606Class IIAvs Anchor-C Cervical Cage SystemStryker Spine / cleared 2011-04-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)