Medtronic Sofamor Danek USA Inc VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Brand
Medtronic Sofamor Danek USA Inc
Lot Codes / Batch Numbers
Product no. 6958838. UDI: 00613994354686.
Products Sold
Product no. 6958838. UDI: 00613994354686.
Medtronic Sofamor Danek USA Inc is recalling VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 due to Nonconforming product; length of the product measured shorter than the labeled length.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Nonconforming product; length of the product measured shorter than the labeled length.
Recommended Action
Per FDA guidance
Medtronic, 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026