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U.S. Department of Health and Human Services

Class 2 Device Recall VERTEX MULTI AXIAL SCREW. 4.0 X 38MM

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 Class 2 Device Recall VERTEX MULTI AXIAL SCREW. 4.0 X 38MMsee related information
Date Initiated by FirmMarch 26, 2020
Create DateMay 08, 2020
Recall Status1 Terminated 3 on March 26, 2021
Recall NumberZ-1941-2020
Recall Event ID 85414
510(K)NumberK081297 
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
ProductVERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Code Information Product no. 6958838. UDI: 00613994354686.
FEI Number 1000477302
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Pl
Memphis TN 38132-1703
For Additional Information ContactEric Epperson
915-344-1435
Manufacturer Reason
for Recall		Nonconforming product; length of the product measured shorter than the labeled length.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionMedtronic, Inc., notified customers on March 31, 2020 via " Urgent Voluntary Market Removal (Recall) Vertex Select Multi Axial Screw (MAS) Product Code 6958838 Lot H5517628. The recall letter identified the affected product and requested the customers to remove the impacted product from normal storage location and complete the return form.
Quantity in Commerce83 units.
DistributionUS Nationwide distribution in the states of CA and MI.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KWP
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