RecallDepth

VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628

Company
Medtronic Sofamor Danek Usa Inc
Recall Initiated
March 26, 2020
Terminated
March 26, 2021
Recall Number
Z-1941-2020
Quantity
83 units.
Firm Location
Memphis, TN

Reason for Recall

Nonconforming product; length of the product measured shorter than the labeled length.

Distribution

US Nationwide distribution in the states of CA and MI.

Lot / Code Info

Product no. 6958838. UDI: 00613994354686.

Root Cause

Nonconforming Material/Component

Action Taken

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.

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