Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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.

FDA Recall Z-3210-2024 · Posted 2024-09-23

Recalling FirmStryker Spine
Recall StatusOpen, Classified
Product CodeOVE
Date Initiated2024-08-23
Product Quantity8,589 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.

Firm 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

Root Cause

Labeling Change Control

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑