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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW

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 Class 2 Device Recall Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREWsee related information
Date Initiated by FirmMarch 23, 2018
Create DateMay 08, 2018
Recall Status1 Terminated 3 on July 25, 2021
Recall NumberZ-1750-2018
Recall Event ID 79792
510(K)NumberK141632 
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
ProductMedtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body
Code Information GTIN/UPN: 643169329218 Lot Number: H5399679
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Pl
Memphis TN 38132-1703
For Additional Information ContactEric Epperson
901-344-1435
Manufacturer Reason
for Recall		Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.
FDA Determined
Cause 2		Process control
ActionThe firm initiated their recall by letter on 03/23/2018. The recall notice requested: "1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via email to rs.sdmriskmgt@medtronic.com. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product. "
Quantity in Commerce39 units
DistributionWorldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France
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 = KWQ
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