Recalls / —

—#180774

Product

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

FDA product code

KWP — Appliance, Fixation, Spinal Interlaminal

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K081297

Affected lot / code info

Product no. 6958838. UDI: 00613994354686.

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

Medtronic Sofamor Danek USA Inc

Address

1800 Pyramid Pl, Memphis, Tennessee 38132-1703

Distribution

Distribution pattern

US Nationwide distribution in the states of CA and MI.

Timeline

Recall initiated

2020-03-26

Terminated

2021-03-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #180774. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.