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

FDA device recall Z-3210-2024 · posted 2024-09-23 · Open, Classified

Recall details

Recalling firm

Stryker Spine

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.

Action taken

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: Spine-egulatoryActions@Stryker.com 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 Spine-RegulatoryActions@Stryker.com, 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

Status

Open, Classified

Product code

OVE

Quantity affected

8,589 units

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Date initiated

2024-08-23

Date posted

2024-09-23

Location

Allendale, NJ

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