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U.S. Department of Health and Human Services

Class 2 Device Recall AVS AnchorC Cervical Cage System

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 Class 2 Device Recall AVS AnchorC Cervical Cage Systemsee related information
Date Initiated by FirmAugust 23, 2024
Date PostedSeptember 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3210-2024
Recall Event ID 95274
510(K)NumberK102606 
Product Classification Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
ProductAVS 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.
Code Information electronic eIFU (revision 5) Rev 5 available January 2023 to present.
FEI Number 3004024955
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information ContactSAME
201-825-4900
Manufacturer 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.
FDA Determined
Cause 2		Labeling Change Control
ActionStryker 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
Quantity in Commerce8,589 units
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OVE
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