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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Infinity

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  Class 2 Device Recall Medtronic Infinity see related information
Date Initiated by Firm February 16, 2023
Date Posted April 19, 2023
Recall Status1 Open3, Classified
Recall Number Z-1409-2023
Recall Event ID 91790
510(K)Number K163375  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
Product INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.
Code Information GTIN 00643169554689, Lot/Batch numbers: H5802983
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Pl
Memphis TN 38132-1703
For Additional Information Contact Kyra Nead
303-886-2549
Manufacturer Reason
for Recall		 Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm issued an URGENT MEDICAL DEVICE RECALL NOTICE to its consignees on 02/16/2023 by UPS 2nd day mail. The letter explained the issue and the risk and requested the following actions be taken: Immediately identify, segregate, and quarantine affected products within your inventory. Pass this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Contact Medtronic to return affected product: 1-800-933-2635 to receive an return authorization (RGA) and coordinate inventory replacement/credit. Reference FA1315. The letter also includes specific patient recommendations.
Quantity in Commerce 45 units
Distribution Worldwide distribution - US Nationwide and the country of Canada.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KWP and Original Applicant = Medtronic Sofamor Danek USA, Inc.
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