Recall Z-3210-2024 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Stryker Spine
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.
| Date | Sep 23, 2024 (initiated Aug 23, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 Re |
| Quantity | 8,589 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102606 | AVS ANCHOR-C CERVICAL CAGE SYSTEM Stryker Spine, Apr 22, 2011 |