Device recall

Z-1941-2020: VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628

FDA device recall · Class II · Medtronic Sofamor Danek USA Inc

Key facts

Recall number (Z-number) Z-1941-2020
Recall event 85414
Product VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Product code KWP
Recalling firm Medtronic Sofamor Danek USA Inc
Recall class Class II
Status Terminated
Termination date Mar 26, 2021
510(k) numbers K081297
FEI number 1000477302

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)